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Terminated

Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064

FDA Recall Z-0936-03 · Posted 2003-06-17

Recalling FirmAbbott Laboratories HPD/ADD
Recall StatusTerminated
Product CodeFPA
Date Initiated2003-05-13
Date Terminated2003-11-20
Product Quantity4,656 units

Reason for Recall

The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL

Firm Action

Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.

Root Cause

Other

Distribution Pattern

Miami, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941214LIFESHIELD EXTENSION SETAbbott Mfg., Inc. · 1994-10-03K865060I.V. SET WITH DUAL-CHANNEL CASSETTEAbbott Laboratories · 1987-02-06K832755INFUSION PUMP & IV SETS #4000Omni-Glow, Inc. · 1983-11-03K791930IV EXTENSION SET SLAbbott Laboratories · 1979-10-26

Official Source

View FDA Recall →

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

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