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

Laparotomy Pack - Customed- Bag Suture Floral Towel recalled

Customed is recalling Laparotomy Pack - Customed- Bag Suture Floral Towel Absorbent 15" X 20" Mayo Stand Cover, 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 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112

Quantity recalled48 lots; 15008 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-2312-2014
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

LAPAROTOMY PACK - CUSTOMED- (1) BAG SUTURE FLORAL (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) DRAPE T LAPAROTOMY STD SMS (2) SHEET DRAPE 42" X 57" (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE 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 Laparotomy Pack - Customed- Bag Suture Floral Towel Absorbent 15" X 20" Mayo Stand Cover recalled?

Yes. Customed recalled Laparotomy Pack - Customed- Bag Suture Floral Towel Absorbent 15" X 20" Mayo Stand Cover on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2312-2014.

Why was it recalled?

Which lots are affected?

Product code 900-176, 48 lots: 110030643 110040905 110081992 111020467 111020499 111030609 111030830 111030932 111051336 111051472 111061512 111071910 111072024 111082068 111092366 111092455 111102645 111112937 111113036 111113163 111123386 111123476 112010091 112010247 112010272 112010285 112020410 112020565 112020570 112030693 112030890 112031006 112041370 112051553 112051879 112062449 112062566 112083377 113099568 131110070 131110404 131110581 131210965 140111413 140211741 140312333 140412794 140513112

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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