Customed, Inc: LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (2) UTILITY BOWL 16oz (2) STERI STRIP CLOSURE W' X 4" (1) ACTIFOG W/FOAM PAD SOLUTION (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM (1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON (1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES (1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall number

Z-2444-2014

Recalling firm

Customed, Inc

Product

LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15" X 20" (2) LEGGINS W/7" CUFF 30" X 42" (1) BLADE SURGICAL #15 STAINLESS STEEL (1) BLADE SURGICAL #11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINFORCED XLG (1) GOWN LGE STANDARD SMS VELCRO NECK (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD (2) UTILITY BOWL 16oz (2) STERI STRIP CLOSURE W' X 4" (1) ACTIFOG W/FOAM PAD SOLUTION (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) NEEDLE ULTRA VERES 120MM (1) STAPLE ARTICULATING ECHEL 60MM (1) RELOAD WHITE 60MM ECHELON (1) RELOAD BLUE 60MM ECHELON (2) CANNULA 5MM XCEL SLEEVES (1) TROCAR 5MM BLADELE WITH STAB SLEEVE (1) TROCAR 12MM BLADELE WITH STAB SLEEVE (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS Product Usage: 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

17 lots/626 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 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501

510(k) numbers

not on file

PMA numbers

not on file

Product code

FDE

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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