Z-0365-2020Class II

Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN...

Name: Z-0365-2020 Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN...
Creator: Cadence Science, Inc.
Published: 2019-05-10
License: https://open.fda.gov/license/

Cadence Inc. / initiated 2019-05-10 / Terminated

FDA source

Cadence Science, Inc. began a recall of Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN... on 2019-05-10. FDA classified it as Class II and gives the reason as "The glass syringe used with Pressure Control Syringes may potentially break during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0365-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-11-13
Terminated: 2020-06-05
Recalling firm: Cadence Inc.
Product: 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
Product code: FMF Syringe, Piston
Reason for recall: The glass syringe used with Pressure Control Syringes may potentially break during use.
FDA root cause: Under Investigation by firm
Action: On May 10, 2019, the firm distributed Advisory Notice letters to affected customers. Customers were advised of the potential issue involving breakage of the glass syringe used with Pressure Control Syringes. The firm recommended that the customer inspect the product for this issue prior to use in accordance with the Instructions For Use (IFU) which were provided with the product. The firm provided an additional IFU with the notification. Upon successful inspection, the firm recommended that customers continue to use the product in accordance with the IFU and continue to follow all OSHA recommendations for the safe handling of chemicals to include PPE. Customers may contact Chuck Funkhouser at 401-942-1031, ext. 4226 or [email protected], or Jeff Crist at 540-245-1022 or [email protected] with any questions.
Quantity in commerce: 237
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0365-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0365-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-13

Product code FMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)