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Terminated

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use

FDA Recall Z-0365-2020 · Posted None

Recalling FirmCadence Science, Inc.
Recall StatusTerminated
Product CodeFMF
Date Initiated2019-05-10
Date Terminated2020-06-05
Product Quantity237

Reason for Recall

The glass syringe used with Pressure Control Syringes may potentially break during use.

Firm Action

On May 10, 2019, the firm distributed Advisory Notice letters to affected customers. Customers were advised of the potential issue involving breakage of the glass syringe used with Pressure Control Syringes. The firm recommended that the customer inspect the product for this issue prior to use in accordance with the Instructions For Use (IFU) which were provided with the product. The firm provided an additional IFU with the notification. Upon successful inspection, the firm recommended that customers continue to use the product in accordance with the IFU and continue to follow all OSHA recommendations for the safe handling of chemicals to include PPE. Customers may contact Chuck Funkhouser at 401-942-1031, ext. 4226 or [email protected], or Jeff Crist at 540-245-1022 or [email protected] with any questions.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.

Official Source

View FDA Recall →

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

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