Reported Sep 10, 2014 · Terminated
Open Heart Pack, code 900-2618, contains
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?
Open Heart Pack, code 900-2618, contains
5 of 5 products
| # | Product as published |
|---|---|
| 1 | MAYO STAND COVER REINFORCED LIF (6) TOWELS ABSORBENT 15" X 20" L/F ( |
| 2 | TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF ( |
| 3 | MAYO TRAY LARGE (8) DRAPE UTILITY WfTAPE LIF (1 ) TABLE COVER REINFORCED 44" X 78" LIF (2) GOWN SURG. SMS POLY-REINF BREATHABLE AAMI IV X-LARGE T/WRAP ( |
| 4 | DRAPE SPLIT CARDIO W/CLEAR ANEST. SC STD SMS ( |
| 5 | SHEET SPLIT BILATERAL 84" X 80" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. |
- Lot codes and dates
900-26187
- lots113078598 113099489 113109819 131110407 140211729 140412561 140513137
- Amount recalled
- 7 lots, 259 packed units, multiple units for 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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