Reported Sep 10, 2014 · Terminated
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER 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?
14 of 14 products
| # | Product as published |
|---|---|
| 1 | MAYO STAND COVER REINFORCED LIF ( |
| 2 | CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( |
| 3 | BULB SYRINGE 60cc LIF ( |
| 4 | TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( |
| 5 | TUBE SUCTION CONNECT. Y.." X 12' LIF ( |
| 6 | SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( |
| 7 | DRAPE % ECONOMY 53" X 77" LIF ( |
| 8 | SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( |
| 9 | SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( |
| 10 | STAPLE SKIN 35 WIDE LIF ( |
| 11 | TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( |
| 12 | SOLUTION SURGICAL DURAPREP 26ml LIF ( |
| 13 | Pk. NEUROPATTIES 0.45MM 10ea/pk ( |
| 14 | Pk. NEUROPATTIES 0.35MM 10ea/pk Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
- Lot codes and dates
Product code 900-19831
- lots131110141
- Amount recalled
- 1 lot; 50 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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