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 Graseby 3300 Pump and Graseby 3000 Seri8es Pump Accessories

  • 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 Graseby 3300 Pump and Graseby 3000 Seri8es Pump Accessoriessee related information
Date Initiated by FirmAugust 24, 2017
Create DateFebruary 01, 2018
Recall Status1 Terminated 3 on May 01, 2020
Recall NumberZ-0497-2018
Recall Event ID 78943
510(K)NumberK915270 
Product Classification Pump, infusion, pca - Product Code MEA
ProductGraseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Code Information Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionNotification was sent to customers on August 24, 2017. Included with the Product Safety & Recall Notification, Instructions to Customers and the Recall response Form. Customers who find product subject to the recall are to contact Smith Medical Customer Service Department to make arrangements to have the affected products returned to Smiths. For further questions, please call (763) 383-3072.
Quantity in Commerce77
DistributionWorldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MEA
-
-