Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOS
FDA device recall Z-1448-2024 · posted 2024-03-29 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
- Action taken
- Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMH
- Quantity affected
- 1700 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama, Canada.
- Date initiated
- 2024-02-23
- Date posted
- 2024-03-29
- Location
- Northfield, IL
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