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U.S. Department of Health and Human Services

Class 2 Device Recall ABL 5 capillary adaptor

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 Class 2 Device Recall ABL 5 capillary adaptorsee related information
Date Initiated by FirmJune 09, 2005
Date PostedAugust 03, 2006
Recall Status1 Terminated 3 on February 24, 2012
Recall NumberZ-1320-06
Recall Event ID 35774
510(K)NumberK943882 
Product Classification in vitro diagnostic accessory - Product Code CHL
ProductABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.
Code Information Part #906-018  lot 041643 to lot 045124
FEI Number 1523456
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information ContactVince Sigmund
800-736-0600
Manufacturer Reason
for Recall		The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results.
FDA Determined
Cause 2		Other
ActionThe firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.
Quantity in Commerce155 bags
DistributionNationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
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 = CHL
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