Recall Z-1755-2025— C.R. Bard Inc
Class I · Ongoing
Class I FDA medical device recall by C.R. Bard Inc, initiated 2025-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber. 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..
- Recalling firm
- C.R. Bard Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-04-17
- Firm location
- Covington, GA, United States
Product description
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.