Reported Sep 10, 2014 · Terminated
D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) 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?
- D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) TRAY MAYO SMALL LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SUTURE BAG FLORAL LIF (1) TUBE SUCTION CONNECT X" X 12' LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) LEGGINGS WITH 7" CUFF 30" X 42" LIF (1) UTILITY BOWL 32oz. UF (1) *FOLEY CATHETER 5CC/2 WAY 16FR SILICONE COATED LATEX (2) DRESSING NON ADH TELFA 4 X 3 ST. UF (1) JELLY LUBRICATING FIVE GRAM (1) TABLE COVER REINFORCED 50" X 90" LIF (1) *Pk. STERI STRIP LAP SET LATEX (1) COVER CAMERA W/ELAST UF (2) GOWN LARGE SMS IMPERVIOUS REINFORCED UF (4) TOWELS ABSORBENT 15" X 20" UF (1) DRAPE LAP. PERINEAL WITH POUCH 102" X 97" SOFT SMS UF (2) LIGHT SHIELD (1) DRESSING TEGADERM 4" X 4 %" LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (1) SCALPEL WEIGHTED SAFETY #11 (1) BAG ZIP LOCK (1) Pk. STRIP STERI CLOSURE W' X 4" LIF (1) TIME OUT BEACON NON WOVEN ST. UF (1) BANDAGE GAUZE STRETCH 4" (1) NEEDLE ULTRA VERES 120MM UF (2) COUNTER NDUBLADE, 10C MAG/CLEAR UF (1) SKIN MARKER INK WITH 8 LABEL !TIME OUT/RULER L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Lot codes and dates
Product code 900-149622
- lots
112041078112051677112062422112114953113015550113025817113026047113036320113036750113057690113067952113088734113099274113109735131110178131210749140111077140211644140311921140412602140513092140513391
- Amount recalled
- 22 lots; 968 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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