Reported Sep 2, 2020 · Ongoing

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U,…

Datascope Corporation

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: Datascope Corporation · 15 Law Dr · Fairfield, NJ · 07004-3206

Lot codes and dates: Kit Lot Number
392 of 392 codes
3000046733
3000047274
3000047604
3000048401
3000049310
3000051066
3000051995
3000053048
3000054067
3000054914
3000057090
3000058631
3000059460
3000060261
3000060731
3000060848
3000062743
3000064057
3000071409
3000065401
3000065942
3000066768
3000067500
3000068688
3000068689
3000070070
3000072315
3000072885
3000083860
3000075682
3000076775
3000079570
3000080053
3000077520
3000077941
3000078503
3000078600
3000078656
3000079242
3000080764
3000081888
3000082186
3000082885
3000083861
3000084565
3000084851
3000085193
3000087974
3000088594
3000088639
3000089730
3000090853
3000091126
3000091327
3000092503
3000093663
3000095290
3000095946
3000096738
3000097654
Amount recalled: 116652 Kits WW

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Potential Endotoxin Contamination

This product could cause temporary or reversible health problems — stop using it.

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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13 in total.