Abbott Medical Recalls
Showing 1-4 of 4 recalls
Radiofrequency Grounding Pad, REF RF-DGP-L
Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.
CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas.
The firm initiated the recall by hand delivered letter on 11/11/2019. The letter explained the issue and requested the return of the recalled product.
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1).
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.