Customed, Inc: Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15" LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 " X 58" SMS (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV (1) VAGINAL SPONGE XRD (1) UMBILICAL CORD CLAMP LIF (2) CLOTH HUCK TOWELS BLUE (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 (1) MUCUSTRAP 20cc 1 OFr. (1) BOWL PLASTIC 80oz WITH LID (1) WRAPPER 24" X 24" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Recall number

Z-2309-2014

Recalling firm

Customed, Inc

Product

Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1) Pr. SURGICAL GLOVE # 7Y2 (1) UNDER BUTTOCK DRAPE WITH POUCH (1) BEANNIES BABY LIF (1) FEEDING TUBE 8 Fr. 15" LONG LIF (1) ABDOMINAL DRAPE WITH TAPE L/F (1) DRAPE SHEET 41 " X 58" SMS (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV (1) VAGINAL SPONGE XRD (1) UMBILICAL CORD CLAMP LIF (2) CLOTH HUCK TOWELS BLUE (1 0) GAUZE SPONGE 4" X 4"16 PLY XRD LIF (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2 (1) MUCUSTRAP 20cc 1 OFr. (1) BOWL PLASTIC 80oz WITH LID (1) WRAPPER 24" X 24" LIF 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

34 lots; 2648 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 900-168, 34 lots: 110061523 110092042 110092166 110092388 110112612 110123053 111010060 111020331 111041058 111051332 111061506 111071775 111082059 111102842 111113023 111123371 112072440 112083401 112114642 112125025 113026049 113036454 113036752 113057838 113078270 113088750 113089158 113109744 131110336 140111166 140211649 140211925 140513102 140513461

510(k) numbers

not on file

PMA numbers

not on file

Product code

OKV

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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