Customed, Inc: ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF (2) ELASTIC BANDAGE 6" X 5yrd LIF (1) TUR Y SET 81 "2.1m REGULAR CLAM (2) NEEDLE HYPODERMIC 18G X 1 ~ (1) TABLE COVER 50" X 90" REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) Pr. NEUTRALON SURGEON GLOVES #7.5 (1) Pr. NEUTRALON SURGEON GLOVES #8 (1) Pr. NEUTRALON SURGEON GLOVES #8.5 (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (10) GAUZE SPONGES 4" X 4" 16PLY XRD (2) STRIPS TAPE (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) DRAPE VIDEO CAMERA LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall number

Z-2338-2014

Recalling firm

Customed, Inc

Product

ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~ LUER LOCK LIF (2) ELASTIC BANDAGE 6" X 5yrd LIF (1) TUR Y SET 81 "2.1m REGULAR CLAM (2) NEEDLE HYPODERMIC 18G X 1 ~ (1) TABLE COVER 50" X 90" REINFORCED LIF (5) TOWEL ABSORBENT 15" X 20" LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) Pr. NEUTRALON SURGEON GLOVES #7.5 (1) Pr. NEUTRALON SURGEON GLOVES #8 (1) Pr. NEUTRALON SURGEON GLOVES #8.5 (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (10) GAUZE SPONGES 4" X 4" 16PLY XRD (2) STRIPS TAPE (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) DRAPE VIDEO CAMERA 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

28 lots; 2620 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 900-620, 28 lots: 111113132 111123276 112010192 112020517 112030733 112041340 112052000 112062500 112072808 112083437 112093729 112114579 112124875 113015455 113025964 113036374 113036444 113068176 113088879 113099447 113109862 131210833 140111241 140211733 140211943 140412839 140513377 140513456

510(k) numbers

not on file

PMA numbers

not on file

Product code

FWZ

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

Copy