Reported Sep 10, 2014 · Terminated
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X…
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?
16 of 16 products
| # | Product as published |
|---|---|
| 1 | NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( |
| 2 | FEEDING TUBE 8FR, 15" LONG ( |
| 3 | BEANNIES BABY ( |
| 4 | SYRINGE 20cc WITHOUT NEEDLE LILOCK ( |
| 5 | UMBILICAL CORD CLAMP ST. ( |
| 6 | RECEIVING BLANKET 100% COTTON ( |
| 7 | TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( |
| 8 | BABY BLANKET 30 X 30 POLY ABS IMPERV. ( |
| 9 | BOWL PLASTIC 80oz ( |
| 10 | LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( |
| 11 | PACKING VAGINAL XRD 4 X 36 8PLY ( |
| 12 | TABLE COVER REINFORCED 50" X 90" ( |
| 13 | DRAPE ABDOMINAL WITH TAPE 40" X 54" (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8" STICK SPONGES ST. ( |
| 14 | EAR ULCER SYRINGE 2oz. ( |
| 15 | GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30" X 30" ( |
| 16 | PVP PAINT 8" STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents |
- Lot codes and dates
Product code 900-41916
- lots
112041449112093941112114601113025847113026169113036364113047313113067871113078327113089073113099292131110077131210815140111228140211670140311939
- Amount recalled
- 16 lots; 1852 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.