FDA Medical Device Recalls (openFDA)
Cadence Inc.: Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209
- Recall number
- Z-2365-2015
- Recalling firm
- Cadence Inc.
- Product
- Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209
- Status
- Terminated
- Initiated
- 2015-07-09
- Posted
- 2015-08-10
- Terminated
- 2016-07-29
- Reason
- Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
- Root cause
- Device Design
- Action
- Cadence issued the recall letter, specific to the customer dated 7/9/15 via registered mail on July 17, 2015. Accounts are requested to Recalled products must not be used. 2. Locate and quarantine all affected products. 3. Contact Cadence Science, Inc. using the Response Form provided. 4. If this information is received by a dealer, wholesaler, or distributor/reseller that distributed any of these products to other facilities, then notify their customers of this action so that those customers can locate and remove all affected products. Any questions contact: Phone: 401-942-1031
- Quantity
- 1665 units
- Distribution
- Nationwide Foreign Canada, Denmark. Italy
- Lot, serial or model codes
- Packged Lots: Catalog Number 5208: 79895-01, 80044-02, 82350-01, W006510/1; Catalog Number 5209: 71880-01, 76434-01, 76461-01, 76461-02, 76461-03, 76461-04, 76461-05, 76461-06, 76461-07, 76461-08, 79748-01, 80044-03, W001711/1, W002337/1, W002886/1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 1213649
- Firm city
- Cranston
- Firm state
- RI
- 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