Converters — Class II medical device recall Z-2757-2017
Terminated recall by Cardinal Health 200, LLC, reported 2017-08-02, distributed nationwide. Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414,
| Recall number | Z-2757-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2017-06-27 |
| Classified | 2017-07-24 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,591 units |
| Reason classes | labeling |
| Lot numbers | 16LFS235 |
| Model numbers | 8482 |
| Expiration dates | 2021-11-01 |
Product
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Reason for recall
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
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-2757-2017. 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.