Reported Sep 10, 2014 · Terminated
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2)…
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?
- SHOULDER PACK CODE 900-2766 CONTENTS(1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) NEEDLE SPINAL ANESTH 18G X 3% LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF (2) ATTACHABLE POUCH BEACH CHAIR 35" X 43" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F (4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17" X 11" LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6" X 48" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 24" X 24" (1) NEEDLE HYPODERMIC 22G X 1 % (1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT (1) MAYO STAND
- COVER REINFORCED LIF Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
- Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666
- Amount recalled
- 6 lots, 171 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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