FDA Device recall Z-2748-2015
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration
- FDA Device
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration by Elcam Medical, citing punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2748-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-19 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Elcam Medical |
| Distribution | NM, PA, TX |
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
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Identifiers
| code_info | Elcam Part Number: 572808; lot numbers: 1270243601, 1070181601, 1170205601, 1070178501, 1070181601, 1070178501 Elc…Elcam Part Number: 572808; lot numbers: 1270243601, 1070181601, 1170205601, 1070178501, 1070181601, 1070178501 Elcam Part Number: 572452; lot numbers: 0870106101, 1070153401,1070157001, 1070174301, 1070178202, 1070178201, 1070181701, 1070181702, 1170188001, 1170201801, 1170206001, 1270215901, 1270217601, 1270219801, 1270225801, 1270227101, 1270227102, 1270227801, 1270228901, 1270235401, 1270235401, 1270237801, 1270241101, 1270248001, 1270248002,1370249601, 1370250401, 1370258101, 1370264101, 1370267501, 1370270901 Elcam Part Number: 573302; lot numbers: 0970142301, 0970146701, 1070153301, 1070159201, 1070164501, 1070170301, 1070171501, 1070180301, 1070182401, 1170185501, 1170185502, 1170188301, 1170189701, 1170190601, 1170198101, 1170203902, 1170210801, 1170203901, 1270214701, 1270214702, 1270217301, 1270221801, 1270223201, 1270229001, 1270239701, 1270245101, 1270247901, 1270247902, 1370249501, 1370252801, 1370252802, 1370258601, 1370265101, 1370265102, 1370270501, 13702736 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2748-2015%22
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