Reported Sep 10, 2014 · Terminated
MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN…
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?
- MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF (5) LAP SPONGE PREWASH XRD L/F (4) DRAPE UTILITY WITH TAPE LIF (2) LITES GLOVE LIF (1) TUBE SUCTION CONNECT. ~" X 12' LIF (1) COVER MAYO STAND REINFORCED LIF (1) UTILITY BOWL 32oz (2) UTILITY BOWL 16oz (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL #10 CARBON STEEL (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BAG SUTURE FLORAL (1) DRAPE SHEET MEDIUM 41" X 69" LIF (1) DRAPE LAP WITH POUCH SMS STD L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Lot codes and dates
Product code 900-173550
- lots
110102434110112619110112893111010068111020366111030604111040842111051280111061589111071909111082065111082258111092365111102646111102700111112936111112963111123380112010087112010246112020405112030642112041200112051874112062448112072785112083406112114610112125032112125313113015434113025948113026232113036783113057399113057692113057813113068157113078569113089200113099567131110069131110403131110580131210964140111412140211885140312330140412886140513347
- Amount recalled
- 50 lots; 9749 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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