Customed, Inc: PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall number

Z-2382-2014

Recalling firm

Customed, Inc

Product

PREMIUM CESAREAN PACK- CUSTOMED- (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL PLASTIC 80oz WITH LID (10) LAP SPONGE PREWASH XRD LIF (2) PAD OBSTETRICAL X-LARGE ST. (1) MAYO STAND COVER REINFORCED LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) EAR ULCER SYRINGE 2oz LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) CORD UMBILICAL CLAMP LIF (1) DRESSING ISLAND 4" X 10" (1) BLADE SURGICAL#10 CARBON STEEL (1) BLADE SURGICAL#20 CARBON STEEL (1) TABLE COVER REINFORCED 50" X 90" LIF (1) C-SECTION DRAPE WITH POUCH (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Status

Terminated

Initiated

2014-05-20

Posted

2014-08-29

Terminated

2017-08-14

Reason

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.

Root cause

Package design/selection

Action

Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Quantity

18 lots; 730 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.

Lot, serial or model codes

Product code 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477

510(k) numbers

not on file

PMA numbers

not on file

Product code

OHM

Firm FEI

2648727

Firm city

Fajardo

Firm state

not on file

Firm country

PR

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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