CLASS I Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Cesarean Pack- Cover Table Reinforced 50" X 90" Towels recalled
Customed is recalling Cesarean Pack- Cover Table Reinforced 50" X 90" Towels Absorbent 15" X 20" Baby Blanket, 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
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-2359-2014
- 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
- Foreign Material
- 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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LID 80oz. (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CORD UMBILICAL CLAMP (1) MUCUSTRAP 20cc, 10FR. (1) BOWL UTILITY 32oz (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) TUBE SUCTION CONNECT. ~"X 12' (1) TIP CAUTERY POLISHER (1) PENCIL CAUTERY ROCKER SWITCH (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) MAYO STAND COVER REINFORCED (10) LAP SPONGES PREWASH 18" X 18" XRD (1) BAG GLASSINE (2) SURGICAL BLADE #10 STAINLESS STEEL (1) EAR ULCER SYRINGE 2oz. (2) LIGHT GLOVE (1) BOWL UTILITY 16oz (4) DRAPE UTILITY WITH TAPE (2) DRAPE SHEET 41 " X 58" SMS (1) ELECTRODE DUAL DEPRES./GROUNDPAD 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.
Questions about this recall
Is Cesarean Pack- Cover Table Reinforced 50" X 90" Towels Absorbent 15" X 20" Baby Blanket recalled?
Yes. Customed recalled Cesarean Pack- Cover Table Reinforced 50" X 90" Towels Absorbent 15" X 20" Baby Blanket on 20 May 2014. The recall is Class I and its status is Terminated. Recall number Z-2359-2014.
Why was it recalled?
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.
Which lots are affected?
Product code 900-921, 16 lots: 110061474 112114590 113026118 113036391 113057414 113057820 113078478 113078607 113099298 113099579 131110080 131110413 131110590 131210974 140111455 140211743
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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|---|---|---|---|---|---|
| Device | CLASS II | Catalog Number: 900277 Suction Catheter Tray 14FR With Sodium recalled | Customed | Sterility | PR |
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| Device | CLASS II | Catalog Number: 900010 Suture Removal KIT Used by medical staff to recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 9001933 Ophtalmic Surgical Pack Used recalled | Customed | Sterility | PR |
| Device | CLASS II | Catalog Number: 900169 Universal Surgical Pack Used by medical staff recalled | Customed | Sterility | PR |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |