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FDA Device recall Z-2371-2014

ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd

On 2014-09-10 the FDA classified a Class I recall of ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd by Customed, citing 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 t….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2371-2014
ClassificationClass I
Statusterminated
Initiated2014-05-20
Published2014-09-10
Last updated2026-09-13 11:53 UTC
CompanyCustomed
DistributionUS

Product

ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) BAG SUTURE FLORAL LIF (1) BLADE SURGICAL #11 CARBON STEEL (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SYRINGE 30cc SLIP TIP LIF (1) TABLE COVER 44" x 90" (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD UF (1) DRAPE SHEET 41 " x 58" SMS UF (1) NEEDLE HYPODERMIC 22G X 1 Y:z (1) NEEDLE HYPODERMIC 18G X 1 Y:z (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (10) GAUZE SPONGES 4" X 4" 16PL Y EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

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.

Identifiers

code_info
Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670…Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2371-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.