Recall Z-2364-2015
Cadence Inc. · initiated July 9, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Codes / lots: Packged Lots: Catalog Number 5202: 79713-04, 80468-05, W003542/1, W006324/1, W006324/2, W006324/3, W006324/4, W006324/5; Catalog Number 5205: 79748-03; Catalog Number 5212: W008136/1, W008686/1, W011240/1, W010905/1, W012135/1, W014053/1, W015838/1, W011240
Reason for recall
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-2364-2015
- Initiated
- July 9, 2015
- Posted by FDA
- August 10, 2015
- Terminated
- July 29, 2016
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 766 units
- Distribution
- Nationwide Foreign Canada, Denmark. Italy
- Recalling firm
- Cadence Inc., Cranston, RI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2365-2015 Class II | Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel. | 07/09/2015Terminated |