Customed, Inc: Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall number

Z-2522-2014

Recalling firm

Customed, Inc

Product

Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTER NEEDLE & BLADE 20C FOAM/MAG LIF ( I) STAPLE SKIN 35 WIDE LIF ( I) TUBE SUCTION CONNECT W' X 12' L/F ( I) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (2) BLADE # I5 CARBON RIB ( I) NEEDLE SPINAL ANEST22G X 3\12 LIF ( I) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE 8.0 POWDER FREE LIF (2) *PR. GLOVE SURG. 6.5 POWDER LATEX (I) GUT PL FAST ABSORB 5-0 (2) SUTURE 2.0 VICRYL 25MM (3) TOWELS ABSORBENT 15" X 20" LIF 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

5 lots/ 32 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

900-3083, 5 lots: 113109930 131210851 131210953 140111437 140312196

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRO

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