Recall archive / FDA device enforcement

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's In... — FDA record Z-0670-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 15 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Cat...
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Classification: Class II
Recalling firm: B Braun Medical Inc
Quantity: 20,694,734 units
Agency-reported status: Ongoing
Source record identifier: Z-0670-2026

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What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date. 2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date. 3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date. 4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date. 5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. 6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. 7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. 8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. 9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. 10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. 11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. 12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. 13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. 14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. 15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. 16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. 17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. 18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. 19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. 20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. 21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. 22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. 23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. 24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. 25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. 27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths. 29. Catalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths. 30. Catalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths. 31. Catalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths. 32. Catalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths. 33. Catalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths. 34. Catalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths. 35. Catalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths. 36. Catalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths. 37. Catalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths. 38. Catalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths. 39. Catalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths. 40. Catalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths. 41. Catalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths. 42. Catalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths. 43. Catalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths. 44. Catalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths. 45. Catalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths. 46. Catalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths. 47. Catalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths. 48. Catalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths. 49. Catalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths. 50. Catalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.

Label field

Details supplied by the agency

Lot, code or applicability

1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date. 2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date. 3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date. 4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date. 5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths. 6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths. 7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths. 8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths. 9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths. 10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths. 11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths. 12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths. 13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths. 14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths. 15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths. 16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths. 17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths. 18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths. 19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths. 20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths. 21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths. 22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths. 23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths. 24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths. 25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths. 26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths. 27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths. 28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths. 29. Catalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths. 30. Catalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths. 31. Catalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths. 32. Catalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths. 33. Catalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths. 34. Catalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths. 35. Catalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths. 36. Catalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths. 37. Catalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths. 38. Catalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths. 39. Catalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths. 40. Catalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths. 41. Catalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths. 42. Catalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths. 43. Catalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths. 44. Catalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths. 45. Catalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths. 46. Catalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths. 47. Catalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths. 48. Catalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths. 49. Catalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths. 50. Catalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Dec 3, 2025
Recall initiation date: Oct 29, 2025
Center classification date: Nov 26, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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