Apheresis Technologies Recalls Plasma Pump Model PP-04a Due to Rotor Failure
Apheresis Technologies is recalling 13 Plasma Pump Model PP-04a units because a rotor stopped during treatment, interrupting flow.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a mechanical failure interrupted a therapeutic procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Apheresis Technologies, Inc. has initiated a recall of 13 units of the Plasma Pump Model PP-04a. This medical device is used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
The recall was initiated on July 9, 2012, following a complaint that a rotor in the PP-04a pump stopped during a therapeutic plasma exchange treatment. This mechanical failure caused an interruption of flow in both the plasma discard line and the replacement fluid line.
The affected units were distributed nationwide. The specific serial numbers involved in the recall are D11003544 through D11003552 and D11003556 through D11003558. Users of this device should check their serial numbers against this list and contact the manufacturer for further instructions.
The recalled product
- Product
- Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
- Manufacturer
- Apheresis Technologies, Inc.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- D11003544 through D11003552 D11003556 through D11003558
Distribution
Distribution scope not specified by the agency.
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