Reported Sep 10, 2014 · Terminated

Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE…

Customed, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Customed, Inc · Calle Igualdad Final #7 · Fajardo, PR · 00738

Is this the product you have?

Open Heart Tray, Pack A, code 900-1196C
contains(1) TABLE COVER REINFORCED L/Free (1) CARDIOVASCU.LAR INCISE DRAPE L/Free (2) 3/4 ABS. REINFORCED SHEET (1) PLASTIC SHEET (5) DRAPE SHEET SMS (18) CLOTH HUCK TOWELS Blue (4) CLOTH HUCK TOWELS White (1 0) ABSORBENT TOWELS L/Free (4) GOWN IMP. BREATHABLE LGE. (3) MAYO STAND COVER L/Free (2) IMPERV. STOCKINETTE (1) WRAPPER 54" X 54" (1) TRAY PLATFORM LGE (1) TABLE COVER HD L/Free (1) WRAPPER 24" X 24"
Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Lot codes and dates: 900-1196C
25
lots
109081948
111020513
111040952
111041136
111051468
111112924
111113162
112010244
112020547
112020554
112051555
112062220
112082996
112083217
112093966
112114785
113015636
113036439
113078353
113109656
131210739
140111446
140312370
140513169
140613799
Amount recalled: 25 lots/ 493 units

This recall covers 233 products

The agency filed one notice per product. You are reading one of them; the other 232 are below.

220 more are in the archive.

Where it was sold

Nationwide
FL
PR

Why it was recalled

Stop using this product now

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Using this product could cause serious injury, illness or death — stop using it now.

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By hazard

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Where it was distributed

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