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Recall Observatory FDA recall evidence

Device 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

Z-0365-2020

May 10, 2019

Class II

Product summary

Firm
Cadence Science, Inc.
Event
Event 83867
Status
Terminated
Classification
Class II
Quantity
237
Official record key
device-enforcement:Z-0365-2020

Official wording

Reason: The glass syringe used with Pressure Control Syringes may potentially break during use.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The glass syringe used with Pressure Control Syringes may potentially break during use.