Reported Sep 10, 2014 · Terminated
BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY…
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?
- BASIC PACK IV (6) CUSTOMED CONTENTS(3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS STD
- XLGE SET IN SLEEVE Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-24693 lots 112020350 112052029 112072722
- Amount recalled
- 3 lots/1300 units (multiple units per lot)
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
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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