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Terminated

Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 1 needless injection site. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

FDA Recall Z-0659-06 · Posted 2006-03-18

Recalling FirmSmiths Medical MD, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2005-12-08
Date Terminated2007-01-05
Product Quantity4 boxes of 40 Admin. Sets (160 sets in total)

Reason for Recall

Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

Firm Action

Affected customers were notified of the recall and asked to return or destroy any unused product.

Root Cause

Other

Distribution Pattern

South Carolina, Australia, Canada and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991599CADD ADMINISTRATION SETSims Deltec, Inc. · 1999-06-15K811933GUARDIAN, VOLUMETRIC CONTROL DELIVERYAvi, Inc. · 1981-07-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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