Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
Reported: April 18, 2018 Initiated: March 15, 2018 #Z-1368-2018
Product Description
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
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.
Details
- Recalling Firm
- Teleflex Medical Europe Ltd
- Units Affected
- 6340 units
- Distribution
- US Nationwide Distribution
- Location
- Athlone
Frequently Asked Questions
What product was recalled? ▼
Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.. Recalled by Teleflex Medical Europe Ltd. Units affected: 6340 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1368-2018.
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