Z-2185-2009

Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile

Name: Z-2185-2009 Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile
Creator: C.R. Bard Access Systems, Inc
Published: 2008-12-04
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2008-12-04 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard Access Systems, Inc began a recall of Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile on 2008-12-04. The reason FDA records is "Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or...". 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-2185-2009
Status: Terminated
Initiated: 2008-12-04
Posted: 2009-09-15
Terminated: 2011-11-09
Recalling firm: Bard Access Systems, Inc.
Product: Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
Quantity in commerce: 177,614 units
Distribution: Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product codes and lots: Lots: 43ARA073, 43DQA028, 43DQA029, 43DQA030, 43FQA053, 43FOA054, 43FQA055, 43FQA056, 43FQA057, 43FQA058, 43FQA059, 43GQA058, 43GQA059, 43GQA060, 43GQA061, 43GQA062, 43GQA063, 43GQA064, 43GQA065, 43HQA053, 43HQA187, 43IQA054, 43JQA055, 43JQA056, 43KQA070, 43KQA071, 43KQA072, 43LQA073, 43LQA074, HURA1470, HURA1471, HURA1472, HURA1473, HURB2558, HURB2559, HURD1498, HURD1644, HURD1798, HURD1799, HURD1800, HURD1801, HURE2820, HURE2821, HURE2822, HURE3300, HURE3301, HURE3302, HURE3303, HURF0404, HURF0405, HURF0406, HURG0210, HURG1382, HURG1383, HURG1384, HURG1385, HURH0869, HURH0870, HURH0871, HURH0872, HURH0873, HURI0518, HURI1003, HURI1203, HURI1204, HURI1205, HURJ0306, HURJ0308, HURJ0309, HURJ0312, HURJ1440, HURK1457, HURK1458, HURK1459, HURK1460, HUSA0275, HUSA0276, HUSB0097, HUSC0158, HUSC0159, HUSC1201, HUSC1763, HUSD0095, HUSD0096, HUSD0097, HUSD0098, HUSD1936, HUSD1937, HUSD1938, HUSD1939, HUSE1505, HUSE1506, HUSE1508, HUSF0001, HUSF1748.

Product code KNT

MDM coverage of this record lists here, newest first.

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)