Reported Sep 10, 2014 · Terminated
GENERAL PACK - CONTENTS
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?
GENERAL PACK - CONTENTS
12 of 12 products
| # | Product as published |
|---|---|
| 1 | NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( |
| 2 | SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( |
| 3 | TABLE COVER REINFORCED 50" X 90" LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( |
| 4 | SURGICAL DURAPREP SOLUTION 26mL LIF ( |
| 5 | LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41" X 58" SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 |
| 6 | GAUZE 4"X 4" X 4 PLY ( |
| 7 | CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( |
| 8 | CAUTERY PENCIL ROCKER SWITCH LIF (1 |
| 9 | GAUZE SPONGE 4" X 4" 16 PLY XRD LIF ( |
| 10 | TUBE SUCTION CONNECT. 3/16" X 12' LIF ( |
| 11 | SURGICAL BLADE# 15 CARBON STEEL ( |
| 12 | CONTAINER SPECIMEN 4 oz. WITH LID & LABEL Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
- Lot codes and dates
Product code 900-200329
- lots
112030702112041277112062472112093923112103923112114386112114472112125311113015438113025954113026205113036457113047011113047156113057447113057696113057814113068159113078779113089205113099569131110221131110405131110582140211725140211874140312378140312461140412832
- Amount recalled
- 29 lots; 2144 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 differ 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Customed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.