Recall archive / FDA device enforcement
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 produ... — FDA record Z-2643-2024
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 Jun 3, 2024. 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
- Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Reason
- During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- Classification
- Class II
- Recalling firm
- Microtek Medical Inc.
- Quantity
- 11,781 cases (589,050 units)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2643-2024
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 | SKU/UDI-Device Identifier: 2008S/00748426002535; Lot Numbers: 210924,190828,190828,190312,190527,190507,190528,190507,181022,190527,181224,190717,181226,181225,190312,190828,190410,180828,190527,190528,180828,181226,211115,210924,210922,210922,210922,210923,210924,210922,210807,210805,210706,210706,210922,210706,210804,210804,210419,210419,210419,210415,210415,210415,210416,210416,210419,210104,210104,210104,201111,201111,201110,201110,201113,201113,201113,201113,201112,201112,201112,201112,201112,201113,201019,201019,201019,200818,200818,200818,200818,200818,200702,200702,200702,200702,190528,190312,181022,190527,190828,181225,181224,190410,190829,181224,180828,190527,190312,181022,181022,181226,190718,180828,190528,190313,190527,181224,181226,181226,190717,181225,181226,230628,230626,230608,230623,230608,230626,230607,230509,230605,230605,230605,230509,230509,230324,230324,230326,230325,230325,221117,221117,221112,221112,221112,221006,211116,211115,211115,211115,220525,220525,220417,220406,220527,220527,220527,220527,220530,220527,220530,220407,220405,220407,220103,220103,220102,220102,220102,181226,190410,190507,190410,211116,211117,210924,210922,210924,210922,210922,210923,210923,210807,210924,210807,210807,210924,210706,210924,210706,210706,210805,210419,210804,210706,210419,210419,210415,210415,210416,210416,210415,210416,210416,210104,210104,210419,210104,201111,201111,201111,201110,201110,201110,201113,201113,201112,201020,201019,200818,190527,190410,230628,230628,230626,230629,230626,230629,230623,230623,230623,230324,230325,230326,221117,220526,211115,220406,220526,220530,220527,220527,220407,220405,220406,220405,220103,220103,220103,220103,200424,190507,181226,230628,230629,230608,230509,220103,220103,210415,181225,211117,210924,201111,201112,200702,181225,190718,230628,190312,181225,181226,180828,181225,181225,211117,211117,211117,211117,211116,210924,210923,210416,200424,210924,210923,210805,210805,210706,210706,210805,210804,210419,210419,210416,210416,210104,210104,201111,201111,201111,201110,201113,201113,201112,201112,201112,201020,201020,201020,200818,200702,200702,200702,200425,200702,200702,190507,190718,181226,181226,190312,190528,181022,181022,181225,190828,181224,181226,190717,230628,230627,230629,230623,230629,230608,230629,230626,230605,230607,230605,230324,230326,230325,230325,230325,221117,221112,211116,211115,220526,220525,220417,220406,220527,220530,220530,220407,220405,220405,220405,220103,220103,220103,220103,190527,181224,190507,190527,181225,190828,180828,190410,181022,190410,211117,211116,210924,210922,210922,210922,210922,210923,210923,210807,210706,210805,210805,210706,210706,210706,210419,210419,210415,210415,210416,210416,210104,210104,210104,201111,201111,201111,201111,201111,201110,201113,201110,201113,201113,201112,201112,201112,201020,201019,201019,201019,201019,200818,200818,200702,200702,200702,190528,181225,181224,181225,190828,190527,190528,181225,190828,180828,190410,181022,190527,190528,190528,190527,181226,190312,190312,181224,190718,190312,180828,190828,181224,181224,180828,181225,190312,190528,230623,230623,230623,230623,230608,230608,230629,230607,230607,230607,230629,230607,230605,230605,230509,230324,230326,230326,230326,230326,230326,230326,230325,230325,221117,221112,221112,221112,221112,220528,211116,220528,220526,211115,211115,211115,211115,220525,220417,220417,220417,220530,220527,220527,220530,220530,220527,220530,220406,220405,220405,220102,220103,220103,220103,220102,220103,220103,211117,211117,210807,210924,230629,230608,230629,230509,230326,230326,230326,221117,221112,211115,220527,220405,220103,200702,210416,201020,180828,211117,181225,190312,211117,211115,210924,210807,210419,210415,210415,210416,210416,210104,201111,201111,201110,201112,201112,201019,200818,200818,200702,190528,181225,181022,190527,180828,190312,190718,181224,190528,181226,180828,181022,190828,181225,181022,210104,201111,201112,201019,201019,181225,221117,230628,230608,230626,230626,230623,230623,230608,230626,230607,230607,230605,230509,230324,230326,230325,221117,221112,211116,220526,211115,220526,220527,220530,220407,220406,220103,210706,201112,190828,180828,230605,230324,221011,220525,220525,220527,190507,181224,181226,211115,210924,210807,201110,201110,181224,190717,220405,220103,220406,220103,210923,210923,210807,210807,210807,210805,210706,201019,201019,230623,210922,210924,210706,201111,201111,200702,210805,210706,210804,210804,210706,210419,210415,210415,210419,210415,210415,210416,210416,210416,230326,211115,211115,220405,210416,210104,210104,210104,210104,210419,201111,201111,201111,201111,201111,201111,201111,201111,201111,201110,201110,201110,211116,181022,210924,210706,230605,230605,220103,220103,210924,210807,181022,230326,220525,220525,230628,230628,230626,230629,230627,230626,230629,230623,230623,230623,230623,230623,230608,230608,230608,230626,230629,230626,230626,230605,230607,230605,230605,230605,230509,230509,230509,230509,230509,230324,230324,230326,230326,230326,221117,221112,221112,221112,221112,221006,211115,22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|
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong.
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
- Aug 28, 2024
- Recall initiation date
- Jun 3, 2024
- Center classification date
- Aug 16, 2024
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.