Elcam Medical, Inc.: Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.

Recall number

Z-2748-2015

Recalling firm

Elcam Medical, Inc.

Product

Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.

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

7,721,580 units

Distribution

Texas, New Mexico and Pennsylvania

Lot, serial or model codes

Elcam Part Number: 572808; lot numbers: 1270243601, 1070181601, 1170205601, 1070178501, 1070181601, 1070178501  Elcam Part Number: 572452; lot numbers: 0870106101, 1070153401,1070157001, 1070174301, 1070178202, 1070178201, 1070181701, 1070181702, 1170188001, 1170201801, 1170206001, 1270215901, 1270217601, 1270219801, 1270225801, 1270227101, 1270227102, 1270227801, 1270228901, 1270235401, 1270235401, 1270237801, 1270241101, 1270248001, 1270248002,1370249601, 1370250401, 1370258101, 1370264101, 1370267501, 1370270901  Elcam Part Number: 573302; lot numbers: 0970142301, 0970146701, 1070153301, 1070159201, 1070164501, 1070170301, 1070171501, 1070180301, 1070182401, 1170185501, 1170185502, 1170188301, 1170189701, 1170190601, 1170198101, 1170203902, 1170210801, 1170203901, 1270214701, 1270214702, 1270217301, 1270221801, 1270223201, 1270229001, 1270239701, 1270245101, 1270247901, 1270247902, 1370249501, 1370252801, 1370252802, 1370258601, 1370265101, 1370265102, 1370270501, 1370273601, 1470287901, 1470288401, 1470289801, 1470290901, 1470290902, 1470298101, 1470300201, 1470302101, 1470303401, 1470305101, 1470305102, 1470305702, 1470305703, 1470305701, 1470307401, 1470310801, 1470310802, 1470310803, 1470314101  Elcam Part Number: 571403; lot numbers: 0970128401, 0970131801, 1070158201, 1070159101, 1070160901, 1070164401, 1170197001, 1170197002, 1170207501, 1270214301, 1270214302, 1270217401, 1270223101, 1270228201, 1270232901, 1270240801, 1270245701, 1370251901, 1370254301, 1370265701, 1370273501, 1370275901, 1470288801, 1470290401, 1470290402, 1470295201, 1470299201, 1470306001, 1470311201, 1470313401  Elcam Part Number: 571803; lot numbers: 0870102901, 1070158101, 1070159001, 1070161501, 1070161502, 1070162501, 1070162502, 1170185001, 1170188101, 1170195201, 1170195202, 1270214401, 1270225701, 1270232801, 1270232802, 1270236201, 1270236202, 1270244001, 1370254401, 1370272801, 1370282301, 1470296301, 1470297301, 1470299301, 1470308101, 1570320201, 1570321901

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

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

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