FDA Medical Device Recalls (openFDA)
Galt Medical Corp: Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
- Recall number
- Z-1592-2010
- Recalling firm
- Galt Medical Corp
- Product
- Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.
- Status
- Terminated
- Initiated
- 2010-02-08
- Posted
- 2010-05-11
- Terminated
- 2011-03-21
- Reason
- Potential problem with pouch seal thus affecting sterile product.
- Root cause
- Packaging process control
- Action
- Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.
- Quantity
- 400 units
- Distribution
- Nationwide Distribution -- MI, PA, IL, & Washington, D.C.
- Lot, serial or model codes
- Lot F0620209
- 510(k) numbers
- ["K000737"]
- PMA numbers
- not on file
- Product code
- DRE
- Firm FEI
- 3000718472
- Firm city
- Garland
- Firm state
- TX
- 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
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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