Reported Sep 10, 2014 · Terminated
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER 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?
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS
10 of 10 products
| Model / number | Product as published |
|---|---|
(4) | LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF |
(1) | SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF |
(1) | SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF |
(1) | STRIP STERI DRAPE LARGE 17" X 23" UF (1) SCALPEL WITH HANDLE #11 |
(1) | COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" |
(2) | RULER FLEXIBLE PLASTIC (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF (1) STRIP STERI CLOSURE%'' X 4" UF |
(1) | GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U |
(1) | SKIN MARKER W/RULER UF (1) NEEDLE HYPODERMIC 25 X 1 % UF |
(1) | DRESSING TELFA 8" X 3" NON ADH UF (1) DRESSING TEGADERM 4 X 4%" UF |
(9) | STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF |
- Lot codes and dates
- Product code 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727
- Amount recalled
- 5 lots/280 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.