Data Foundry

Medical device recalls 2015

Elcam Medical MANI 3G Plate BLS RAD B — Class II medical device recall Z-2749-2015

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 numberZ-2749-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmElcam Medical, Inc., Hackensack, NJ, United States
Recall initiated2015-07-19
Classified2015-09-10
Reported by FDA2015-09-16
Terminated2017-09-18
DistributedNM, PA, TX
Countries outside the USMX
Quantity248,100
Lot numbers1270239001, 1270244201, 1270244901, 1370254802, 1370255001, 1370255601, 1370256602, 1370261201, 1370261301, 1370261401, 1370261501, 1370263901, 1370266601, 1370266701, 1370266801, 1370271301, 1370271501, 1370271701, 1370271702, 1370271801, 1370271901, 1370274101, 1370278601, 1370278602, 1370278801, 1370278901, 1370279001, 1370282101, 1470288601, 1470288602, 1470288701, 1470292401, 1470292402, 1470293001, 147029310, 1470293201, 1470295901, 1470296001, 1470296101, 1470296201 and 25 more
Model numbers470306, 470307, 471601, 471604, 477101, 477102, 477901, 477904, 478003, 478004, 478701, 478704

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 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-2749-2015. 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.