FDA Medical Device Recalls (openFDA)
Gambro Renal Products: Gambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
- Recall number
- Z-0307-03
- Recalling firm
- Gambro Renal Products
- Product
- Gambro ClinicalKit Safety Kit 15G, Catalog Number 0141080405C. Packaged 30 kits per case. Each kit contains 2 Nipro Safetouch Safety Needles.
- Status
- Completed
- Initiated
- 2002-11-13
- Posted
- not on file
- Terminated
- not on file
- Reason
- Gambro's ClinicalKit 15G safety Kits contain the Nipro Safetouch Safety Fistula Needles currently being recalled by Nipro for leakage problems
- Root cause
- not on file
- Action
- All consignees were notified by telephone and fax on 11/13/2002.
- Quantity
- 2,160 kits
- Distribution
- Domestic distribution to CO, IL, MO and VA. No military, government or foreign consignees.
- Lot, serial or model codes
- Gambro ClinicalKit Safety Kit 15G. Catalog No. 0141080405C. Lots 05H154001, 04H154007, 04H154010, 04H154011..
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- not on file
- Firm city
- Lakewood
- Firm state
- not on file
- 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