Recall archive / FDA device enforcement
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.0... — FDA record Z-1691-2023
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 Apr 17, 2023. 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
- Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.
- Reason
- The custom procedure packs contain light handle covers that have been recalled by another firm.
- Classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 1,391 cases (2,972 packs)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1691-2023
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) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, GTIN pack-00749756363549, case-50749756363544; (12) 89-10553.02 - lot 58544060, exp 11/1/2024, GTIN pack-00749756363624, case-50749756363629; (13) 89-10554.02 - lot 58544166, exp 12/1/2024, GTIN pack-00749756363440, case-50749756363445; (14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, GTIN pack-00749756363648, case-50749756363643; (15) 89-10556.02 - lot 58589567, exp 12/1/2024, GTIN pack-00749756364287, case-50749756364282; (16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, GTIN pack-00749756364430, case-50749756364435; (17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, GTIN pack-00749756363778, case-50749756363773; (18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, GTIN pack-00749756363723, case-50749756363728; (19) 89-10562.02 - lot 58621820, exp 10/1/2024, GTIN pack-00749756364140, case-50749756364145; (20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, GTIN pack-00749756363761, case-50749756363766; (21) 89-10569.02 - lot 58544182 exp 12/1/2024, GTIN pack-00749756363457, case-50749756363452; (22) 89-10570.02 - lot 58700739, exp 1/1/2024, and 58775036, exp 3/14/2024, GTIN pack-00749756363587, case-50749756363582; (23) 89-10574.02 - lot 58700641, exp 7/1/2024, GTIN pack-00749756364041, case-50749756364046; (24) 89-10575.02 - lot 58565848, exp 12/1/2023, GTIN pack-00749756366144, case-50749756366149; (25) 89-10576.03 - lot 58700704, exp 12/1/2024, GTIN pack-00749756364126, case-50749756364121; (26) 89-10580.03 - lot 58543454, exp 8/1/2024, GTIN pack-00749756366328, case-50749756366323. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 14, 2023
- Recall initiation date
- Apr 17, 2023
- Center classification date
- Jun 7, 2023
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.