FDA Medical Device Recalls (openFDA)
Radiometer America Inc: SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
- Recall number
- Z-1443-06
- Recalling firm
- Radiometer America Inc
- Product
- SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623.
- Status
- Terminated
- Initiated
- 2006-07-18
- Posted
- 2006-08-29
- Terminated
- 2011-09-14
- Reason
- Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps.
- Root cause
- Other
- Action
- The firm sent a recall letter to their customers on 7/18/2006. The letter identifies the problem, as well as the Part Numbers and Lot Numbers for the defective safePICO syringes subject to recall. The letter requests that the customers: 1) Examine their inventories for the presence of the affected part numbers and lot numbers; 2) Identify and discard any of the affected product found on-hand; and 3) Return the attached FAX FORM indicating the amount of replacement product required and the address to which the replacement product should be mailed. The letter also provides a telephone number to reach the firm's Technical Support Department should the customer have any questions concerning the recall letter.
- Quantity
- 448 boxes x 100 per box [44,800 pouches]
- Distribution
- Nationwide distribution --- including the states of MO, WI, DC, FL, MI, CA, CO, GA, KS, KY, PA, TX, and SD.
- Lot, serial or model codes
- The recalled product is identified with the following Part Numbers/Order No.; Lot Numbers; and Expiration Dates: Part #956-610, Lot #RD-28, and Expiration Date: 2008-01; Part #956-612, Lot #RJ-05, and Expiration Date: 2008-02; Part #956-614, Lot #RL-30, Expiration Date: 2008-03, Part #956-616, Lot #RQ-02, Expiration Date: 2008-04; and Part #956-623, Lot Code: RL22, and Expiration Date:2008-03
- 510(k) numbers
- ["K043143"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- 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