Reported Sep 10, 2014 · Terminated
AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV…
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?
- AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCTION CONNECT "Y-1" X 12' LIF (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF (2) LITE GLOVE LIF (1) BOWL UTILITY 32oz LIF (2) BOWL UTILITY 16oz LIF (10) LAP SPONGE PREWASH XRD LIF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 18G X 1 % (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF (1) COVER MAYO STAND REINFORCED LIF (1) COVER TABLE 44" X 90" (1) MAYO TRAY SMALL (2) ABSORBENT TOWEL 15" X 20" UF (1) BOWL WITH LID PLASTIC 80oz EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Lot codes and dates
Product code 900-192221
- lots
110112626112010102112030659112041213112051899112062468112081922113025826113036785113057439113078286113088772113089202113109767131110213140111080140111186140211803140312097140312460140412890
- Amount recalled
- 21 lots; 684 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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