Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45 (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32 (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teleflex Medical Europe Ltd
- Reason for Recall:
- These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Simplastic Suprapubic Puncture Instruments: Product Code Equivalent Code (a) 650704100 551310 (b) 650704120 551312 (c) 650704160 551316 Product Usage: RUSCH Simplastic Suprapubic Puncture Instruments are indicated for emergency suprapubic drainage of the bladder.
Product Codes/Lot Numbers:
Product Code Equivalent Code (a) 650704100 551310 Batch Numbers: 13HE35 14KE45 (b) 650704120 551312 Batch Numbers: 13EE20 13HE35 13JE43 14AE02 14BE07 14EE21 14GE29 14IE39 15AE03 15HE32 (c) 650704160 551316 Batch Numbers: 13GE31 13HE35 13JE41 13JE42 13JE43 13KE48 14AE03 14BE07 14CE11 14DE17 14DE18 14EE21 14EG21 14GE28 14HE33 14HE35 14IE39 14KE45 15AE03 15EE20 15EE22 15GE28 15JE43 15JE44 13EG28 13HG23
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1369-2018
Related Recalls
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
Teleflex Medical Europe
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.