PlainRecalls
FDA Devices Critical Class I Terminated

CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) R

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2430-2014

Product Description

CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Details

Recalling Firm
Customed, Inc
Units Affected
14 lots; 420 units (multiple units per lot)
Distribution
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.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled? ▼
CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP SPONGES PRE-WASHED XRD LIF (2) PAD OBSTETRICAL XLGE (1) BABY BEANNIES (1) MAYO STAND COVER REINFORCED L/F (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' L/F (1) EAR ULCER SYRINGE 2oz. LIF (1) RECEIVING BLANKET 100% COTION (1) YANKAUER SUCT TUBE WITHOUT VENT L/F (1) UMBILICAL CORD CLAMP (2) WRAPPER 20"X 20" (1) DRESSING ISLAND 4" X 10" (1) SCALPEL# 10 WITH HANDLE S/S (1) SCALPEL# 20 WITH HANDLE (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO TRAY SMALL (1) MUCUSTRAP 20cc 1 OFr. (2) GOWN LGE SMS IMPERVIOUS REINFORCED (1) SURGICAL DURAPREP SOLUTION 26mL L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Recalled by Customed, Inc. Units affected: 14 lots; 420 units (multiple units per lot).
Why was this product recalled? ▼
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2430-2014.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →