FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL 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.
- Recall number
- Z-1320-06
- Recalling firm
- Radiometer America Inc
- Product
- ABL 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.
- Status
- Terminated
- Initiated
- 2005-06-09
- Posted
- 2006-08-03
- Terminated
- 2012-02-24
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 155 bags
- Distribution
- Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.
- Lot, serial or model codes
- Part #906-018 lot 041643 to lot 045124
- 510(k) numbers
- ["K943882"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28