Recall Z-1566-2020 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cook Inc.
Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
| Date | Mar 6, 2020 |
| Status | Terminated |
| Reason | The printed expiration dates are incorrect. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall notification letter dated 3/6/2020 was distributed to customers. Actions to be Taken by the Customer 1.Examine inventory immediately to determine if you have affected product(s) and quarantine anyaffected product that remains unused. Immediately cease all distribution and use of this product. 2.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement andReceipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form forreturn instructions. Note: Unaffected products that are returned will not be credited. 3.Please |
| Quantity | 25 |
| Distribution | The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033843 | SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING Cook, Inc., Aug 12, 2004 |