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Terminated

Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.

FDA Recall Z-0865-2011 · Posted 2011-01-06

Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeLJS
Date Initiated2010-12-10
Date Terminated2011-05-04
Product Quantity195 units

Reason for Recall

Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.

Firm Action

BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.

Root Cause

Employee error

Distribution Pattern

Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.

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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