Reported Sep 10, 2014 · Terminated

REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML…

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?

REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4" 16PLY ( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E ( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL (5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE ( I} TUR Y SET, 2LEAD UF ( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING ( I} ROUND WASH BASIN 6QT. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Lot codes and dates: Product code 900-1460
29
lots
109050945
111123344
112010046
112020337
112041074
112051759
112062229
112062272
112083031
112083391
112093722
112114564
112124948
113015428
113036592
113047001
113047147
113057686
113067887
113078253
113078702
113089190
131110174
131210632
140111081
140211866
140311920
140312391
140513089
Amount recalled: 29 lots; 1521 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

Nationwide
FL
PR

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.

By hazard

Other recalls from Customed, Inc.

Where it was distributed

All recall categories · Browse the whole archive