Reported Sep 10, 2014 · Terminated
LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) 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?
17 of 17 products
| # | Product as published |
|---|---|
| 1 | STRIP STERI CLOSURE W' X 4" LIF ( |
| 2 | TABLE COVER REINFORCED 50" X 90" LIF ( |
| 3 | DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( |
| 4 | GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (4) DRAPE UTILITY WIT APE LIF ( |
| 5 | COVER CAMERA W/ELAST LIF (2) GAUZE SPONGE 4" X 4" 12PL Y LIF ( |
| 6 | NEEDLE ULTRA VERES 120mm LIF (2) DRAPE SHEET 41 " X 58" SMS LIF ( |
| 7 | SCALPEL WEIGHTED SAFETY #11 ( |
| 8 | TUBING INSUFFLATING OPEN TIP W/0 VENT LIF ( |
| 9 | DRESSING TEGADERM 4" X 4 %" LIF ( |
| 10 | TUBE SUCTION CONNECT X" X 12' LIF ( |
| 11 | MAYO STAND COVER REINFORCED LIF ( |
| 12 | SUTURE BAG FLORAL LIF ( |
| 13 | Pk. STERI STRIP LAP SET LATEX ( |
| 14 | CORD LAPAROSCOPY MONOPOLAR LIF ( |
| 15 | MAYO TRAY SMALL LIF ( |
| 16 | TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF ( |
| 17 | BAG ZIP LOCK PLASTIC 6" X 10" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
- Lot codes and dates
Product code 900-41426
- lots
112030868112041328112051656112062284112072802112093940112104108112114600113015696113025963113036361113036800113057485113068047113068170113088863113089072113099574131110261131210813140111100140211669140311938140412466140412887140513363
- Amount recalled
- 26 lots; 2192 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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