FDA Medical Device Recalls (openFDA)
Elcam Medical, Inc.: 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
- Recall number
- Z-2749-2015
- Recalling firm
- Elcam Medical, Inc.
- 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
- Status
- Terminated
- Initiated
- 2015-07-19
- Posted
- 2015-09-10
- Terminated
- 2017-09-18
- Reason
- Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
- Root cause
- Packaging
- Action
- Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
- Quantity
- 248,100
- Distribution
- Texas, New Mexico and Pennsylvania
- Lot, serial or model codes
- 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: 478004; lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801 Elcam Part Number: 478701; lot numbers: 1270244901, 1370261301, 1370271901 Elcam Part Number: 478704; lot numbers: 1470296201, 1470299101, 470307201, 1470312901
- 510(k) numbers
- ["K122953"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003649401
- Firm city
- Hackensack
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28