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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71880

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 19, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Elcam Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2748-2015
Recall number
Z-2748-2015
Initiated
July 19, 2015
Classification
Class II
Status
Terminated
Recalling firm
Elcam Medical, Inc.
Quantity
7,721,580 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

Code information

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

Distribution pattern

Texas, New Mexico and Pennsylvania

device · product 2 of 2

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

Z-2749-2015
Recall number
Z-2749-2015
Initiated
July 19, 2015
Classification
Class II
Status
Terminated
Recalling firm
Elcam Medical, Inc.
Quantity
248,100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.

Code information

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

Distribution pattern

Texas, New Mexico and Pennsylvania