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Terminated

GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271

FDA Recall Z-1077-04 · Posted 2004-07-20

Recalling FirmAbbott Labs
Recall StatusTerminated
Product CodeFRN
Date Initiated2004-05-11
Date Terminated2004-10-20
Product Quantity18,432 units

Reason for Recall

The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25C (77 F).

Firm Action

Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.

Root Cause

Other

Distribution Pattern

Total number of consignees that received product: 13. Five are wholesale dealers, None are distributors, 8 are retailers. Product has been distributed worldwide, and in the United States: AR, Washington DC, FL, IL, KY, LA, MA, MD, MN, MO, NJ, TX. Also sent to National Institute of Health, Bethesda, MD, (301) 496-4000

Official Source

View FDA Recall →

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

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