Recall Z-2639-2024 ยท KPE Container, I.V.
Microtek Medical Inc.
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
| Date | Aug 16, 2024 (initiated Jun 3, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Consignees were notified via email and letter on 06/03/2024. The consignees were instructed to "Segregate Recalled Product/immediately examine the inventory for the lots listed above and remove all products from inventory regardless of its location and segregate this product in a secure location. The lot number can be found on the individual package or case label. If the consignee has affected product in their possession, please dispose of the product and packaging in accordance with hospital, administrative and /or local government policy. If the consignee is unable to dispose of the product, |
| Quantity | 10,366 cases (518,300 units) |
| Distribution | Distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811233 | I.V. PLASTIC BAG Medi-Plast Intl., Inc., Jun 17, 1981 |