Recall Z-0506-2020 ยท JOL Catheter And Tip, Suction
Cook Inc.
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
| Date | Sep 17, 2019 |
| Status | Terminated |
| Reason | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device. |
| Root cause | Under Investigation by firm |
| Action | On September 17, 2019, the firm notified consignees of the recall by mailing Urgent Medical Device Recall letters. The letter alerted customers that if the affected product is used, they may experience increased procedural time to obtain a replacement and local or systemic infection. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement a |
| Quantity | 41 units |
| Distribution | US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.