Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall for a medical device where the hazard—disconnection of a syringe-manifold connection during angiography—creates a direct risk of serious harm to patients. Although no reported illnesses or injuries are stated in the source text, the nature of the device use and the Class I designation under the rubric places this at Severe (score 4).
Plain-English summary
The Halyard SAMMC ANGIOGRAPHY kit (Model Number SAMM066-15), manufactured by AVID Medical, Inc., is being recalled due to a potential risk that the Medline syringe rotating adapter may unwind during use. This unwinding could result in a loose connection and/or full disconnection between the syringe and manifold.
Approximately 2,392 kits have been distributed within the United States to medical facilities in FL, IL, MO, MS, NC, NE, and TX. The affected kits are identified by UDI-DI 10809160388495 and the following lot numbers: 1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932.
Healthcare providers and users of these kits should cease use of the recalled lots immediately. AVID Medical, Inc. is coordinating with the FDA on this recall (FDA Recall Number Z-1978-2026). Users should contact AVID Medical or their local healthcare facility for instructions on returning or replacing the affected kits.
The recalled product
- Product
- Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- connection-failure
- device-malfunction
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 (20)
- Model Number: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685
- 1575926
- 1583048
- 1584017
- 1589652
- 1595715
- 1599634
- 1605749
- 1611810
- 1621476
- 1637222
- 1637224
- 1637225
- 1643118
- 1645143
- 1645637
- 1663929
- 1663930
- 1663931
- 1663932).
Distribution
Distributed in 7 states:
- FL
- IL
- MO
- MS
- NC
- NE
- TX