Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product
FDA device recall Z-1445-2024 · 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
- MCZ
- Quantity affected
- 23,290 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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