ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers),
FDA device recall Z-1320-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- 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.
- Action taken
- The 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 155 bags
- Distribution
- Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
- Date initiated
- 2005-06-09
- Date posted
- 2006-08-03
- Date terminated
- 2012-02-24
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM (K943882) | Radiometer America, Inc. | 1995-03-10 |