FDA Medical Device Recalls (openFDA)
Abbott Labs: GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
- Recall number
- Z-1077-04
- Recalling firm
- Abbott Labs
- Product
- GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
- Status
- Terminated
- Initiated
- 2004-05-11
- Posted
- 2004-07-20
- Terminated
- 2004-10-20
- Reason
- 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).
- Root cause
- Other
- Action
- Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.
- Quantity
- 18,432 units
- Distribution
- 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
- Lot, serial or model codes
- 95-156-5H, 05-027-5H, 09-208-5H
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3004072476
- Firm city
- Morgan Hill
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28