ClearanceBrief
Recall Z-2365-2015 ยท GAA Needle, Aspiration And Injection, Disposable

Cadence Inc.

Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209

DateAug 10, 2015 (initiated Jul 9, 2015)
StatusTerminated
ReasonGraduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
Root causeDevice Design
ActionCadence 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
Quantity1665 units
DistributionNationwide Foreign Canada, Denmark. Italy
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.