Reported Sep 10, 2014 · Terminated
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X…
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- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STRIPS TAPE 24" X 4" L/F (1) STOCKINETTE 6" X 48" LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125" x 85" SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30" X 37" (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Lot codes and dates
Product code 900-90211
- lots
112041360112051755112052021113015521113025983113036389113067942113078352140312189140412917140513342
- Amount recalled
- 11 lots; 273 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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