FDA recall Z-0069-2018

Product

AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.

Reason for recall

Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.

Distribution

US Distribution to the state of : SC

Key facts

Status

Terminated

Initiation date

2017-10-24

Report date

2017-11-15

Termination date

2018-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2018