Reported Sep 10, 2014 · Terminated
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH…
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?
- Arthroscopy Pack,900-2609
- contains(5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X 12' (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2" X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON STEEL (1) GOWN SURG REINFORCED LGE TOWEL WRAP (2) GOWN XL SMS IMPERVIOUS REINFORCED (2) LITE GLOVE (1) STOCKINETTE IMPERVIOUS 12" X 48" (1) TABLE COVER REINFORCED 50" X 90"
- Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-26097
- lots131210795 140111213 140211829 140312136 140412660 140513133 140513402
- Amount recalled
- 7 lots (9 packs per lot, 63 packs)
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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