FDA DevicesClass II
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418...
Published: May 27, 2026Recall ID: Z-2226-2026Category: devicesCountry: US
Reason for Recall / Hazard
Due to stain present on the surface of affected foley catheters.
Product Description & Identification
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Affected Products
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Additional Source Details
| Field | Value |
|---|---|
| City | Covington |
| State | GA |
| Event id | 98716 |
| Address 1 | 8195 Industrial Blvd Ne |
| Code info | Silastic Brand Foley Catheter 30cc Catalog Number / UDI code: 33416 / 00801741019982 10801741019989 Lot Number: NGKX0444 33418 / 00801741019999 10801741019996 Lot Number: NGKW2813 33420 / 00801741020001 10801741020008 Lot Number: NGKQ1015 33422 / 00801741020018 10801741020015 Lot Number: NGKW3707 33424 / 00801741020025 10801741020022 Lot Number: NGKW2669 Silastic Brand Foley Catheter 5cc Catalog Number / UDI code: 33614 / 00801741020056 10801741020053 Lot Numbers: NGKN4037 NGKP1420 NGKQ0040 NGKQ3901 NGKS4937 NGKV3462 NGKW3897 33616 / 00801741020063 10801741020060 Lot Numbers: NGKQ0042 NGKQ3946 NGKR3420 NGKT3281 NGKU1015 NGKV0617 NGKV2275 NGKV2309 NGKW3771 33618 / 00801741020070 10801741020077 Lot Numbers: NGKQ3370 NGKS3753 NGKT3258 NGKT3309 NGKU4129 NGKV1446 NGKV2345 NGKV3478 NGKV5029 33620 / 00801741020087 10801741020084 Lot Numbers: NGKS5060 NGKT3308 NGKV3689 33622 / 00801741020094 10801741020091 Lot Numbers: NGKQ1016 NGKS0244 NGKU0967 NGKV5075 NGKX0441 33624 / 00801741020... [TRUNCATED] |
| Postal code | 30014-1497 |
| Report date | 20260527 |
| Product type | Devices |
| Product quantity | 106,160 |
| Reason for recall | Due to stain present on the surface of affected foley catheters. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260423 |
| Initial firm notification | Letter |
| Center classification date | 20260521 |
Overview
- Recalling FirmC.R. Bard Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI O.U.S.: Canada