Z-0865-2011

Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard...

Name: Z-0865-2011 Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard...
Creator: Bard Access Systems
Published: 2010-12-10
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2010-12-10 / Terminated / root cause: manufacturing process

FDA source

Bard Access Systems began a recall of Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. The... on 2010-12-10. The reason FDA records is "Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0865-2011
Status: Terminated
Initiated: 2010-12-10
Posted: 2011-01-06
Terminated: 2011-05-04
Recalling firm: Bard Access Systems, Inc.
Product: 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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 195 units
Distribution: Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.
Product codes and lots: Lot numbers: REUF1011, REUF1303.

Product code LJS

K926331Class II3.0 Fr Groshong Peripher Insert Cent Venous CathBard Access Systems, Inc. / cleared 1994-03-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)