Taut Intraducers 10/BX7 — Class II medical device recall Z-0277-2016
Terminated recall by Teleflex Medical, reported 2015-11-25, distributed nationwide. The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum,
| Recall number | Z-0277-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2015-10-14 |
| Classified | 2015-11-16 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 2,050 units |
| Reason classes | packaging |
| Lot numbers | 73A1500175, 73A1500306, 73B1500116, 73B1500418 |
Product
Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.
Reason for recall
The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another 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-0277-2016. 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.