Reported Sep 10, 2014 · Terminated
PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1)…
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?
- PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP
- Lot codes and dates
Product code 900-129651
- lots
110102576110112604110112865110122889110123065111010033111020358111030562111030827111030934111041085111051267111051325111061488111061600111061645111072036111082183111082197111092481111102671111112927111123333112010033112010243112020326112030613112041246112041437112062581112114631112124934112125280113015634113025909113036727113047212113047323113068143113078567113078691113089183113109718131110066131110595131210958140111405140211870140412595140412882140513344
- Amount recalled
- 51 lots; 11070 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.
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.