Belly Bag Urine Collection Bag with Hip Belt — Class II medical device recall Z-1158-2013
Terminated recall by Teleflex Medical, reported 2013-05-01. Sterile packaging may be compromised.
| Recall number | Z-1158-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-04-22 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-05-01 |
| Countries outside the US | AU, CA, DE, IE, JP, NZ, SG |
| Quantity | 190,103 |
| Reason classes | sterility |
| Model numbers | 02A1100488, 02A1100489, 02A1100490, 02A1100491, 02A1100492, 02A1100493, 02A1100494, 02A1101100, 02A1101101, 02A1101420, 02A1101421, 02A1102009, 02A1102010, 02A1102049, 02A1102050, 02A1102051, 02A1102052, 02A1103180, 02A1103181, 02A1103182, 02A1103183, 02A1103184, 02A1201862, 02A1201868, 02A1201869 and 404 more |
Product
Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Reason for recall
Sterile packaging may be compromised.
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-1158-2013. 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.