Reported Sep 16, 2015 · Terminated
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration.…
Elcam Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elcam Medical, Inc. · 2 University Plz Ste 620 · Hackensack, NJ · 07601-6224
Is this the product you have?
- Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration
- Manufactured byElcam Medical ACAL, Israel
- Distributed byElcam Medical Inc., USA. Sterile
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 470306Elcam 470307lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401 Elcam 471601lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901 Elcam 471604lot numbers: 1270239001, 1370266601, 1370271501, 1370278801 Elcam 477101lot numbers: 147029310, 1470306801, 1470310201, 1470312501 Elcam 477102lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601 Elcam 477901lot numbers: 1370261201, 1570323201 Elcam 477904lot number: 1370255601 Elcam 478003lot number: 1470300101 Elcam 478004lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201 Elcam 478701lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801 Elcam 478704lot numbers: 1270244901, 1370261301, 1370271901 Elcam — lot numbers: 1470296201, 1470299101, 470307201, 1470312901 - Amount recalled
- 248,100
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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