Device product

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Z-2531-2021

August 05, 2021

Class II

Product summary

Firm: C.R. Bard Inc
Event: Event 88499
Status: Ongoing
Classification: Class II
Quantity: 33,380 units
Official record key: device-enforcement:Z-2531-2021

Official wording

Reason: There is potential for packaging defects that may impact the sterile barrier.

Code information: Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10)

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is potential for packaging defects that may impact the sterile barrier.