Z-2749-2015Class II

Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid...

Name: Z-2749-2015 Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid...
Creator: Elcam Medical, Inc.
Published: 2015-07-19
License: https://open.fda.gov/license/

Elcam Medical, Inc. / initiated 2015-07-19 / Terminated / root cause: packaging

FDA source

Elcam Medical, Inc. began a recall of Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL... on 2015-07-19. FDA classified it as Class II and gives the reason as "Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2749-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-19
Posted: 2015-09-10
Terminated: 2017-09-18
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
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
Root cause tag: packaging
FDA 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 in commerce: 248,100
Distribution: Texas, New Mexico and Pennsylvania
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2749-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2748-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10
Z-2749-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-10

Product code LZG

K122953Class IIOmnipod Insulin Managment SystemInsulet Corporation / cleared 2012-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)