SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿… — Class II medical device recall Z-0987-2014
Terminated recall by B. Braun Medical, Inc., reported 2014-02-26, distributed nationwide. Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufacture
| Recall number | Z-0987-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2014-01-08 |
| Classified | 2014-02-18 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,357,944 |
| Reason classes | packaging |
| Lot numbers | 0061324733, 0061326956, 0061330803, 0061332459, 0061333063, 0061333582, 0061333591, 0061333662, 0061334116, 0061335969, 0061338023, 0061338909, 0061339123, 0061339694, 0061339741, 0061343285, 0061345558, 061329867, 061335025, 61313363, 61314531, 61314532, 61314535, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303, 61324238, 61326267, 61326405, 61327038, 61329535, 61330199, 61330221, 61331458, 61336490, S61315790 |
| Model numbers | 351559, 352016, 352079, 352448, 473017, 473309, 474563, 490028, 490213, 7B0110, 7B3179, 7B3240, S5401118N, S5401150N, SS3140 |
| Expiration dates | 2015-09-30, 2015-11-30, 2018-07-31, 2018-08-31, 2018-09-30, 2018-10-31 |
Product
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Reason for recall
Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.
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-0987-2014. 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.