CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report

Pery Gyn Pack- Customed- Drape Abdominal With Tape Uf Towel recalled

Customed is recalling Pery Gyn Pack- Customed- Drape Abdominal With Tape Uf Towel Absorbent 15" X 20" Uf, distributed nationwide in the US. The recall was initiated on 20 May 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451

Quantity recalled56 lots; 5040 units (multiple units per lot)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2372-2014
FDA event ID: 68536
Recalling firm: Customed, Fajardo, PR
Classification: Class I
Status: Terminated
Recall initiated: 20 May 2014
FDA classified: 29 Aug 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

20 May 2014	Recall initiated by company
29 Aug 2014	Classified by FDA	+101 days
10 Sep 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PERY GYN PACK- CUSTOMED- (1) DRAPE ABDOMINAL WITH TAPE UF (1) TOWEL ABSORBENT 15" X 20" UF (2) LEGGINGS W/7" CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" UF (1) DRAPE UNDERBUTTOCK WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Where it was distributed

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Nationwide Florida Puerto Rico

Questions about this recall

Is Pery Gyn Pack- Customed- Drape Abdominal With Tape Uf Towel Absorbent 15" X 20" Uf recalled?

Yes. Customed recalled Pery Gyn Pack- Customed- Drape Abdominal With Tape Uf Towel Absorbent 15" X 20" Uf on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2372-2014.

Why was it recalled?

Which lots are affected?

Product code 900-1091, 56 lots: 110020286 110030631 110040867 110051180 110071617 110081956 110092110 110092379 110112598 110123050 111010018 111020258 111020449 111030543 111051225 111051262 111061481 111071752 111071879 111082042 111092470 111102655 111112944 111112979 111123313 112010019 112020307 112030825 112041390 112041451 112051726 112062316 112072825 112083159 112083381 112093855 112124920 113015425 113025927 113026164 113036314 113047314 113057381 113057855 113078235 113078673 113099267 131110152 131110594 131210957 140111404 140211917 140312390 140412827 140513064 140513451

Where was it sold?

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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