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

Cesarean Pack - - Mayo Stand Cover Reinforced Lif Lap recalled

Customed is recalling Cesarean Pack - - Mayo Stand Cover Reinforced Lif Lap Sponges Pre-wash Xrd Lif Umbilical, 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 900-410, 24 lots: 112020166 112020534 112030841 112041322 112051983 112062488 112072871 112083430 112093939 112114673 112125090 113025992 113036358 113036764 113078476 113078814 113099291 113099573 131110300 140111223 140211668 140312159 140412838 140513349

Quantity recalled24 lots; 2564 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-2322-2014
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

CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X- LARGE LIF (5) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE (1) RECEIVING BLANKET 100% COTTON (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF 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 Cesarean Pack - - Mayo Stand Cover Reinforced Lif Lap Sponges Pre-wash Xrd Lif Umbilical recalled?

Yes. Customed recalled Cesarean Pack - - Mayo Stand Cover Reinforced Lif Lap Sponges Pre-wash Xrd Lif Umbilical on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2322-2014.

Why was it recalled?

Which lots are affected?

Product code 900-410, 24 lots: 112020166 112020534 112030841 112041322 112051983 112062488 112072871 112083430 112093939 112114673 112125090 113025992 113036358 113036764 113078476 113078814 113099291 113099573 131110300 140111223 140211668 140312159 140412838 140513349

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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