Reported Sep 10, 2014 · Terminated
ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC…
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?
10 of 10 products
| # | Product as published |
|---|---|
| 1 | FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( |
| 2 | TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( |
| 3 | GOWN IMPERVIOUS REINFORCED LARGE SMS ( |
| 4 | GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( |
| 5 | GUIDEWIRE .035" X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( |
| 6 | SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( |
| 7 | NEEDLE HYPODERMIC 18G X 1 % ( |
| 8 | SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( |
| 9 | UTILITY BOWL 16oz. LIF ( |
| 10 | SCALPEL WITH HANDLE # 11 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
- Lot codes and dates
Product code 900-61026
- lots
111123130111123272112010190112030731112041339112051998112062498112093947112114578112125303113025825113026192113036373113036696113047161113057494113067874113078337113089077113109860131110268131210661140111087140211673140311942140513221
- Amount recalled
- 26 lots; 1305 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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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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