Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CarePoint

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CarePointsee related information
Date Initiated by FirmSeptember 03, 2020
Date PostedDecember 13, 2022
Recall Status1 Completed
Recall NumberZ-0478-2023
Recall Event ID 91092
510(K)NumberK132553 
Product Classification Syringe, piston - Product Code FMF
ProductCarePoint 60 mL Syringe Without Needle, REF: 04-7560
Code Information UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522
FEI Number 1000138447
Recalling Firm/
Manufacturer		 Allison Medical, Inc.
8091 Shaffer Pkwy
Littleton CO 80127-3716
Manufacturer Reason
for Recall		Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 9/3/20, and later on 3/2/21, recall notices were emailed to customers who were informed to stop using and destroy or return affected devices to the recalling firm. Customers with additional questions could contact the recalling firm at 801-510-8733.
Quantity in Commerce2,004 Boxes
DistributionUS: IA, LA, MS, FL, PR; OUS: BARBADOS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = FMF
-
-