FDA Medical Device Recalls (openFDA)
Customed, Inc: LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL ABSORBENT 15" X 20" L/F (1) TABLE COVER REINFORCED 50" X 90" L/F (1) *LAPAROSCOPIC WOUND CLOSURE LATEX (1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF (4) DRAPE UTILITY WITH TAPE L/F (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Recall number
- Z-2329-2014
- Recalling firm
- Customed, Inc
- Product
- LAPAROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE % ECONOMY 53" X 77" LIF (1) TUBE SUCTION CONNECT. v.i" X 12' LIF (1) SCALPEL WITH HANDLE #11 (1) DRAPE LAP ABDOMINAL WITH POUCH 1 02" X 122" X 78" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (8) TOWEL ABSORBENT 15" X 20" L/F (1) TABLE COVER REINFORCED 50" X 90" L/F (1) *LAPAROSCOPIC WOUND CLOSURE LATEX (1) DRAPE LASER CAMERA WITH/EL 6" X 96" LIF (4) DRAPE UTILITY WITH TAPE L/F (3) GOWN IMPERVIOUS REINFORCED X-LARGE SMS L/F 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
- 39 lots; 1712 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 900-486, 39 lots: 109102328 109112574 109122809 110010090 110020385 110030671 110030811 110051245 110071697 110102446 110112662 111010131 111020373 111030681 111041112 111113120 111123259 111123435 112020536 112030844 112051987 112093629 112114394 112114481 112114571 113015453 113025988 113036367 113057489 113067929 113099436 113109846 131110263 131210820 140111233 140312167 140412470 140412907 140513249
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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