Elcam Medical Minimal Residual Volume Luer activated Swabbable… — Class II medical device recall Z-2748-2015
Terminated recall by Elcam Medical, Inc., reported 2015-09-16, distributed in NM, PA, TX. Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for
| Recall number | Z-2748-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elcam Medical, Inc., Hackensack, NJ, United States |
| Recall initiated | 2015-07-19 |
| Classified | 2015-09-10 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2017-09-18 |
| Distributed | NM, PA, TX |
| Countries outside the US | MX |
| Quantity | 7,721,580 units |
| Lot numbers | 0870102901, 0870106101, 0970128401, 0970131801, 0970142301, 0970146701, 1070153301, 1070153401, 1070157001, 1070158101, 1070158201, 1070159001, 1070159101, 1070159201, 1070160901, 1070161501, 1070161502, 1070162501, 1070162502, 1070164401, 1070164501, 1070170301, 1070171501, 1070174301, 1070178201, 1070178202, 1070178501, 1070180301, 1070181601, 1070181701, 1070181702, 1070182401, 1170185001, 1170185501, 1170185502, 1170188001, 1170188101, 1170188301, 1170189701, 1170190601 and 106 more |
| Model numbers | 571403, 571803, 572452, 572808, 573302 |
Product
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
Reason for recall
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
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-2748-2015. 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.