Reported Sep 10, 2014 · Terminated
LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1)…
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?
- LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4" X 3" (1) TUBE SUCTION CONNECT Y4" X 12' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-48425
- lots
110112811110123129111010130111030679111040976111051201111071818111082100111092392111092547111123258112020476112041331112072873112083432112093945113026060113026073113036489113036802113067928113088868113109845131210819140211845
- Amount recalled
- 25 lots; 552 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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