MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN:10884521006782 / 20884521006789 LOT Numbers: Lot Number 1907700087 1915800147 1915800149 1924500084 1924500085 1924500087 1924500088 1933000070 1933000071 1933000073 1934300131 1934300134 1934300135 1934300136 1934400128 1934400174 1935100073 1935100074 1935100085 1935100086 1935100087 1935100088 2000700065 2000700066 2002100112 2002100114 2002900106 2003900122 2003900123 2005500062 2005500064 2006500075 2007800071 2007800072 2007800073 2009200094 2009300094 2009300095 2009300096 2010800205 2011300096 2011300098 2011300099 2017400084 2018800018 2018800021 2018800023 2019500195 2019500198 2029700145 2032300067 2032800039 2032800040 2033100068 2033100069 2104100115 2122900118 2122900159 2122900161 2122900195 2122900217 2122900276 2122900277 2123000092 2123000115 2124600186 2124600190 2127300095 2131200168 2131200172 2131200175 2131200178 2131200179 2133700137 2133700138 2133700140 2230400265 2230400277 2230400278 2234800082
- 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:
- Covidien LP
- Reason for Recall:
- Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
Product Codes/Lot Numbers:
GTIN:10884521006782 / 20884521006789 LOT Numbers: Lot Number 1907700087 1915800147 1915800149 1924500084 1924500085 1924500087 1924500088 1933000070 1933000071 1933000073 1934300131 1934300134 1934300135 1934300136 1934400128 1934400174 1935100073 1935100074 1935100085 1935100086 1935100087 1935100088 2000700065 2000700066 2002100112 2002100114 2002900106 2003900122 2003900123 2005500062 2005500064 2006500075 2007800071 2007800072 2007800073 2009200094 2009300094 2009300095 2009300096 2010800205 2011300096 2011300098 2011300099 2017400084 2018800018 2018800021 2018800023 2019500195 2019500198 2029700145 2032300067 2032800039 2032800040 2033100068 2033100069 2104100115 2122900118 2122900159 2122900161 2122900195 2122900217 2122900276 2122900277 2123000092 2123000115 2124600186 2124600190 2127300095 2131200168 2131200172 2131200175 2131200178 2131200179 2133700137 2133700138 2133700140 2230400265 2230400277 2230400278 2234800082
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2386-2023
Related Recalls
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting