Reported Sep 10, 2014 · Terminated
ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF…
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?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | TABLE COVER 44" X 90" (4) DRAPE UTILITY WITH TAPE L/F ( |
| 2 | DENTURE CUP WITH LID ( |
| 3 | UTILITY BOWL 16oz. (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR L/F (4) RUBBER BAND ( |
| 4 | NEEDLE HYPODERMIC 27G X 1 Y.." ( |
| 5 | SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (3) CAP NURSE 21 " GREEN BOUFFANT (3) MASK SURGICAL BLUE 120MM HG LIF ( |
| 6 | PREPPING PAD WITH CUFF (2) TIP ABSORB. APPLIC. STICK SPONGE L/F ( |
| 7 | SCALPEL WEIGHTED SAFETY # 11 ( |
| 8 | PROBE DRAPE ST 6" X 96" NO GEL LIF ( |
| 9 | WRAPPER 30" X 30" (3) TOWELS ABSORBENT 15" X 20" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
- Lot codes and dates
Product code 900-193712
- lots
111082312111113057112020431112051902112062289113025829113026168113067902113088773131210660140211699140312423
- Amount recalled
- 12 lots; 190 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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