Pneumothorax Tray — Class II medical device recall Z-0506-2020
Terminated recall by Cook Inc., reported 2019-11-27, distributed nationwide. Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray,
| Recall number | Z-0506-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-09-17 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 41 units |
| Reason classes | sterility |
| Lot numbers | 9850522 |
| Model numbers | C-UTPTY-1400-WAYNE-112497-IMH, G56537 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0506-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.