Reported Sep 10, 2014 · Terminated
UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK…
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?
- UNIVERSAL PACK - (1) UTILITY BOWL 16oz. (1) NEEDLE SPINAL ANEST. 22G X 31!2 (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 20G X 1 1!2 (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (1) SPLIT SHEET WITH ADHESIVE 108" X 77" SMS STD LIF (1) DRAPE % ECONOMY 53" X 77" UF (2) TOWEL ABSORBENT 15" X 20" UF (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y (4) TOWELS CLOTH HUCK BLUE (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (3) PK. CLOSURE SKIN W' X 4" STERI STRIP UF (1) SKIN MARKER WITH RULER (1) DENTURE CUP 8oz WITH LID (1) NEEDLE HYPODERMIC 25 X 1 1!2 (1) STOCKINETTE IMPERVIOUS 14" X 48" (2) TIP ABSORB. APPLICATOR STICK SPONGE (1) TRAY ORGANIZER FULL DEEP (1) TRA 2/COMPARTMENT (1)
- RULER L/F Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-193622
- lots
110082088110082207110102439110112627110112928111010082111030630111041100111051372111061520111071785111113056111123422112010103112041214112062469112083415113109769131210637140111090140312098140412891
- Amount recalled
- 22 lots; 312 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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