Z-0365-2020 Class II Terminated
FDA device recall Z-0365-2020 was initiated by Cadence Science, Inc. on May 10, 2019 and is designated Class II. Reason for recall: The glass syringe used with Pressure Control Syringes may potentially break during use. The recall status is terminated (terminated June 5, 2020). Affected quantity: 237.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- May 10, 2019
- Termination Date
- June 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 237
Product Description
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
Reason for Recall
The glass syringe used with Pressure Control Syringes may potentially break during use.
Distribution Pattern
US Nationwide distribution in the states of AL, AR, CA, FL, GA, IA, ID, IL, MO, NH, NJ, NY, OH, PA, SC, TX, VA, and WI.
Code Information
Catalog Number 5338: W037053/1, W037199/1, W037450/1, W040276/1, W042297/1, W040804/1, W045558/1, W049244/1; Catalog Number 5339: W020584/1; Catalog Number 5340: W033034/1, W046909/1, W047793/1, W048648/1, W049141/1, W049853/1, W050262/1, W051186/1; Catalog Number 5341: W029677/1, W037708/1, W040478/1, W043484/1, W049850/1, W051158/1; Catalog Number 5342: W026119/1, W034575/1, W044966/1, W045378/1, W045956/1, W046139/1, W048329/1, W049083/1, W049786/1, W051013/1, W052622/1; Catalog Number 5343: W030380/1, W039777/1, W040479/1