Teleflex Recalls RUSCH Pocket PAC Intermittent Catheter Kits Due to Labeling Error
Teleflex Medical is recalling RUSCH Pocket PAC Intermittent Catheter Kits because they are labeled with expiration dates that exceed the validated shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Teleflex Medical is recalling 102,843 units of RUSCH Pocket PAC IC Intermittent Cath Kits in 8 FR, 10 FR, 12 FR, 14 FR, and 16 FR sizes. The recall is due to a labeling inconsistency where the products are marked with expiration dates that exceed the actual, validated 35-month shelf life.
The affected products were distributed nationwide to California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, and Texas. The kits are prescription-only and sterile, intended for intermittent self-catheterization.
Consumers and healthcare providers should stop using the affected lots and contact Teleflex Medical for further instructions. The specific lot numbers and product codes are listed in the official FDA recall notice Z-0771-2017.
The recalled product
- Product
- RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 102,843
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)
- Product Code: 10096080
- Lot number: 74F1501853 (8 FR)
- Product Code: 10096120
- Lot numbers: 74E1602795
- 74F1503201
- 74G1600723 & 74J1500576 (12 FR)
- Product Code: 10096140
- Lot numbers: 74A1600023
- 74A1601105
- 74A1602234
- 74D1602007
- 74E1602235
- 74E1602796
- 74F1501855
- 74G1600486
- 74H1500530 & 74L1500363 (14 FR)
- Product Code: 10096100
- Lot numbers: 74A1600799
- 74A1600800
- 74A1602236
Distribution
Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02