Z-1135-03

96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 44805; 650 drip...

Name: Z-1135-03 96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 44805; 650 drip...
Creator: Abbott Laboratories HPD/ADD
Published: 2003-06-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-06-09 / Terminated / root cause: manufacturing process

FDA source

Abbott Laboratories HPD/ADD began a recall of 96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968369, Ashland... on 2003-06-09. The reason FDA records is "The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin". 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-1135-03
Status: Terminated
Initiated: 2003-06-09
Posted: 2003-06-27
Terminated: 2004-08-27
Recalling firm: Abbott Medical
Product: 96-8369 Micro Drip Chambers, Convertible with Pierce Pin Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968369, Ashland Product #85-56030
Product code: FPA Set, Administration, Intravascular
Reason for recall: The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The IV administration sets were recalled by letters dated 6/9/03, advising the accounts of the discoloration of the sight chamber and adapters due to the use of non-radiation grade plastic resin in the manufacture of these components of the sets and requesting the return of the sets for credit. These letters were accompanied by a customer ship history/business reply form, which listed the specific set list numbers and lot numbers shipped to the direct account. The direct accounts were requested to send copies of the enclosed recall letter with the listing of all affected sets to their subaccounts. Abbott sent recall letters dated 6/13/03 to those accounts who received I.V. set list 018810458, lot 910824W packed in cases with Liposyn II 20% Kits, list 97920403, lot 92552DF and list 97930403, lot 94553DF. These accounts were informed of the problem with the administration sets and were requested to remove the sets from the Liposyn II cases and return the sets for credit. Abbott sent recall letters dated 7/7/03 to distributors and veterinary clinics receiving the 12 additional lots of primary I.V. sets, list numbers 018810448 and 089620448, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 7/7/03 to the third party manufacturers receiving the affected drip chamber components, informing them of the problem with the drip chambers and requesting the return of the affected lots. Abbott sent recall letters dated 8/19/03 to hospitals and distributors receiving the 9 additional lots of I.V. sets, list numbers 119440402, 119480402, 120300412, 122590402 and 123120401, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 5/13/04 to hospitals and distributor
Quantity in commerce: 109,200 drip chambers
Distribution: Nationwide and Internationally to Abbott affiliates in Argentina, Aruba, Australia, the Bahamas, Barbados, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Croatia, Curacao, Dominican Republic, Ecuador, Egypt, El Salvador, France, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, Italy, Jordan, Kuwait, Mexico, New Zealand, Nicaragua, Pakistan, Panama, Paraguay, Peru, Suadia Arabia, Singapore, Taiwan, Trinidad, Turkey, United Arab Emirates and Uruguay
Product codes and lots: Abbott Commodity 968369, Ashland Product #85-56030, lots 86B482BR1, 86B48LBMP, 88C12LBMP

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)