Recall Z-0222-2022 ยท DRC Trocar
Cook Inc.
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
| Date | Oct 8, 2021 |
| Status | Terminated |
| Reason | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. |
| Root cause | Nonconforming Material/Component |
| Action | On October 8, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement a |
| Quantity | 31,502 US (30,166 OUS) |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.