Recall Z-0867-2024
Aesculap Inc · initiated December 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Codes / lots: UDI-DI 4046955075379 Firm did not identify affected lots or expiration date. Affected product was distributed between November 23, 2022 and October 6, 2023.
Reason for recall
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
FDA-determined cause: Nonconforming Material/Component
Action taken
On December 29, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE RECALL NOTIFICATION letters. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.
Details
- Recall number
- Z-0867-2024
- Initiated
- December 29, 2023
- Posted by FDA
- January 31, 2024
- Product code
- HCF – Instrument, Ligature Passing And Knot Tying
- Quantity
- 60
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, ID, KY, MD, MO, MT, NV, NY, OR, PA, RI, TN, TX, VA.
- Recalling firm
- Aesculap Inc, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0866-2024 Class II | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC…Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R… | 12/29/2023Open, Classified |