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Terminated

LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Prepierced Injection Site, Prepierced Secondary Port and Option-Lok for use with Plum Series Infusers; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11664-03

FDA Recall Z-0134-06 · Posted 2005-11-15

Recalling FirmHospira Inc.
Recall StatusTerminated
Product CodeBRZ
Date Initiated2005-09-29
Date Terminated2007-11-29
Product Quantity172,872 sets

Reason for Recall

Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

Firm Action

Hospira sent product recall letters dated 9/29/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possibility of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. The accounts were requested to examine their inventory for the affected lots, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.

Root Cause

Other

Distribution Pattern

Nationwide, including Puerto Rico, and internationally to Australia, Mexico, Canada, Taiwan and Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941214LIFESHIELD EXTENSION SETAbbott Mfg., Inc. · 1994-10-03K920736IVEX-HP96 EXTENDED LIFE FILTER SETAbbott Laboratories · 1993-04-23K865060I.V. SET WITH DUAL-CHANNEL CASSETTEAbbott Laboratories · 1987-02-06K830014HEMA - NV TRANS. BLOOD FILTER 100/800Abbott Laboratories · 1983-01-17

Official Source

View FDA Recall →

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

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