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Terminated

Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50" X 90" LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) SHEET DRAPE 42" X 57" SMS LIF (1) SHEET DRAPE 70" x 100" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall Z-2530-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity1 lot/ 45 units

Reason for Recall

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.

Firm 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

Root Cause

Package design/selection

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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