Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Reported: July 24, 2024 Initiated: June 11, 2024 #Z-2408-2024
Product Description
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Reason for Recall
A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
Details
- Recalling Firm
- Canadian Hospital Specialties Ltd.
- Units Affected
- 6300 units
- Distribution
- US Nationwide distribution in the state of MA.
- Location
- Oakville
Frequently Asked Questions
What product was recalled? ▼
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator. Recalled by Canadian Hospital Specialties Ltd.. Units affected: 6300 units.
Why was this product recalled? ▼
A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2408-2024.
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