I.V. Extension Sets recallZ-0956-03 · Abbott Laboratories HPD/ADD · initiated Jun 9, 2003

Why it was recalled

The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.

FDA root cause category: Other

What the company is doing

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

Recall details

Recall number

Z-0956-03

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jun 9, 2003

Posted by the FDA

Jun 27, 2003

Recalling firm

Abbott Laboratories HPD/ADD

Quantity

3,667,374 sets

Product code

FPA

FDA submissions

K915571, K920736, K941214, K970855, K991932

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 description

I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.

Other devices under the same FDA submission

11 devices cleared under K915571, K920736, K941214, K970855, K991932 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ICU Medical 011-MC100

  Icu Medical, Inc. · Set, administration, intravascular
  1 death93 reports
• ICU Medical B3300

  Icu Medical, Inc. · Set, administration, intravascular
  68 reports
• ICU Medical 011-C3300

  Icu Medical, Inc. · Set, administration, intravascular
  31 reports
• ICU Medical C1000

  Icu Medical, Inc. · Set, administration, intravascular
  22 reports
• ICU Medical 12568

  Icu Medical, Inc. · Set, administration, intravascular
  16 reports
• ICU Medical 11956

  Icu Medical, Inc. · Set, administration, intravascular
  12 reports
• ICU Medical 12512-01

  Icu Medical, Inc. · Set, administration, intravascular
  6 reports
• ICU Medical 011-C1000

  Icu Medical, Inc. · Set, administration, intravascular
  5 reports
• ICU Medical 011-A1000

  Icu Medical, Inc. · Set, administration, intravascular
  3 reports
• ICU Medical MC100-GR

  Icu Medical, Inc. · Set, administration, intravascular
  1 report
• ICU Medical SC9020

  Icu Medical, Inc. · Set, administration, intravascular
  1 report