FDA Medical Device Recalls (openFDA)
Nipro Medical Corporation: NIPRO Safe Touch Safety Scalp Vein Set
- Recall number
- Z-1834-2014
- Recalling firm
- Nipro Medical Corporation
- Product
- NIPRO Safe Touch Safety Scalp Vein Set
- Status
- Terminated
- Initiated
- 2013-05-04
- Posted
- 2014-06-19
- Terminated
- 2015-03-02
- Reason
- There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
- Root cause
- Component design/selection
- Action
- Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621. Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.
- Quantity
- 176,000 pieces
- Distribution
- Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.
- Lot, serial or model codes
- Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.
- 510(k) numbers
- ["K011297"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 1000132332
- Firm city
- Miami
- Firm state
- FL
- 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