Arterial blood sampling kits recalled over a crack on the syringe collar
ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.
What this means for you
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: Scored 3 under the risk-of-harm criterion: the firm states a cracked collar may cause blood leakage and repeated procedures, and no injuries are reported.
Plain-English summary
The Pulsator Arterial Blood Sampling Kit, item numbers 4044EG-1, 4080P-2, 4084P-1, 4080PE and 4080PG, is being recalled by ICU Medical Inc.
Affected lots of syringes may have a crack on the syringe collar, which the firm states may lead to delayed or repeated blood draw or fluid delivery. The record adds that the issue may also lead to blood leakage during sampling of arterial blood, or leakage during fluid delivery.
The record lists 64,290 units in total, with UDI-DI 30351688073062 for 4044EG-1 and 30351688006176 for 4080P-2, and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States, in California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas and Washington. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected lots and follow ICU Medical's instructions.
The recalled product
- Product
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Manufacturer
- ICU Medical Inc.
- Affected units
- 64,290
Distribution
Part of a larger recall action
This product is one of 2 recalled by ICU Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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