SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
- 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:
- B. Braun Medical, Inc.
- Reason for Recall:
- Complaints were received reporting leakage on certain lots of SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites.The SAFSITE¿ Injection Site is intended to provide needle free access on IV and Extension Sets.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites. A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Product Codes/Lot Numbers:
Catalog #351559: batch #s 0061339694, exp. 9/30/2018, 0061338909,exp. 9/30/2018, 0061333582, exp. 8/31/2018; catalog # 352016, batch # 0061326956, exp. 10/31/2018; catalog # 352079, batch #0061333591, exp. 8/31/2018; catalog #352448, batch # 0061334116, exp.9/30/2018; catalog #473017, batch #0061332459, exp. 8/31/2018; catalog # 473017, batch #061335025, exp. 9/30/2018; catalog #473309, batch #s 0061343285, exp. 10/31/2018; calatog #473309, lot #061329867, exp. 9/30/2018, 0061339741, exp. 9/30/2018, 0061333662, exp. 8/31/2018; catalog #474563, batch #s 0061338023, exp. 10/31/2018, 0061333063, exp. 8/31/2018; catalog #490028, batch # 0061324733, exp. 8/31/2018; catalog #490213, batch #s 0061330803, 9/30/2015, 0061345558, exp. 11/30/2015; catalog # SS3140, batch # 0061339123, exp. 9/30/2015; catalog #7B0110, batch #s61315790, 61315791, 61317168, 61317170, 61318428, 61318430, 61318850, 61322303,61326405, 61327038, 61330199, 61331458, all NonSterile, No Expiration Date; catalog # 7B3179, batch #s 61313363, 61314531, 61314532, 61314535, 61330221, all NonSterile, No Expiration Date; catalog #7B3240, batch #s 61324238, exp. 8/31/2018; 61329535, exp. 9/30/2018; 61336490, exp. 7/31/2018; catalog # S5401118N, batch #0061335969, Bulk Non-Sterile, No Expiration Date; and catalog #S5401150N, batch #61326267, NonSterile; No Expiration Date.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0987-2014
Related Recalls
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).