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Terminated

BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

FDA Recall Z-0619-2009 · Posted 2009-01-13

Recall StatusTerminated
Product CodeMEG
Date Initiated2008-11-24
Date Terminated2009-03-27
Product Quantity334,400 units

Reason for Recall

Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03.

Firm Action

Recall letters were sent on November 24, 2008 to all direct customers and potential end users of the product by UPS second day air. BD requests that inventory be examined and affected product be quarantined and returned as per recall letter instructions. Questions should be directed to BD customer service at 888-237-2762, M-F 8.OO AM to 5:00 PM EST.

Root Cause

Incorrect or no expiration date

Distribution Pattern

GA, KS, OH, MO, FL, PA, KY and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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