FDA Device recall Z-2749-2015
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN
- FDA Device
- Class II
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class II recall of Elcam Medical MANI 3G Plate BLS RAD B.BRAUN 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-2749-2015 |
| 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 MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Reason
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Identifiers
| code_info | Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 147028…Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401 Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901 Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801 Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501 Elcam Part Number: 477101; lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601 Elcam Part Number: 477102; lot numbers: 1370261201, 1570323201 Elcam Part Number: 477901; lot number: 1370255601 Elcam Part Number: 477904; lot number: 1470300101 Elcam Part Number: 478003; lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201 Elcam Part Number |
|---|
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-2749-2015%22
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