Recall Z-1758-2025 ยท KNT Tubes, Gastrointestinal (And Accessories)
C.R. Bard Inc
Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
| Date | May 20, 2025 (initiated Apr 17, 2025) |
| Status | Open, Classified |
| Reason | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. |
| Root cause | Device Design |
| Action | On April 17, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Correction" Notification to affected consignees. BD asked consignees to take the following actions: 1. Follow the above plastic plug removal instructions. 2. Post this notice where the devices are stored. 3. Please check all inventory locations within your institution for affected products 4. Share this notice with any users of the product within your facilities or with any interfacility users where product was transferred 5.Complete and return the attached Customer Response Form to the BD contact |
| Distribution | US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.