Reported Sep 10, 2014 · Terminated
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. 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?
- PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT 15" x 20" LIF (1) COVER MAYO STAND REINFORCED LIF (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF (1) COVER TABLE REINFORCED 50" x 90" LIF (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
- Lot codes and dates
Product code 900-12937
- lots110092130 111041087 112020325 112051676 112051745 112062348 112083385
- Amount recalled
- 7 lots; 720 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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