Customed, Inc: MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED (4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Recall number

Z-2321-2014

Recalling firm

Customed, Inc

Product

MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2) LIGHT SHIELD (1) MAYO STAND COVER REINFORCED (4) ABSORBENT TOWELS 15" X 20" (2) DRAPE SHEET 41" X 58" SMS (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (2) GOWN XL SMS IMPERV. REINFORCED (1) SUTURE BAG FLORAL (1) TIME OUT BEACON NON WOVEN (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SKIN MARKER W/8/LABEL/TIME OUT/RULER 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

35 lots; 11472 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 900-404, 35 lots: 102030840 111030924 111041044 111051296 111061668 111123243 112010164 112020524 112041317 112041373 112041448 112062487 112083429 112114599 112125087 112125314 113025961 113036355 113036763 113047220 113057480 113057846 113068046 113078323 113078574 113089071 113099290 113099572 131110410 131110587 131210971 140111452 140211742 140412837 140513247

510(k) numbers

not on file

PMA numbers

not on file

Product code

PHI

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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