Mederi Stretta Catheter Recalled Due to Sterility Compromise
Mederi Therapeutics is recalling 1,458 Stretta Catheter kits because a breach in the sterile barrier package compromised sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source indicates a breach in the sterile barrier package, which poses a significant risk of infection or serious injury to patients.
Plain-English summary
Mederi Therapeutics, Inc. is recalling 1,458 units of the Mederi Stretta Catheter and Accessory Kit, Sterile (REF 175-5580). The recall is due to a breach in the sterile barrier package, which compromised the sterility of the product. This device is used in the treatment of gastroesophageal reflux disease (GERD) and is intended for use only with the MEDERI MDRF1 Generator.
The affected lots were distributed nationwide and to the countries of Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan, and Egypt. The specific lot numbers involved are: 291ST-16, 102ST-16, 102ST-16R-1, 102ST-16R-2, 116ST-16R, 116ST-16R2, 116ST-16R3, 116ST-16R4, 139ST-16, 139ST-16-1, 139ST-16-2, 139ST-16-3, 144ST-16, 209ST-16, 227ST-16, 243ST-16, 276ST-15, 286ST-16, 290ST-16, 291ST-16, 299ST-16, 306ST-16, and 310ST-15.
Healthcare providers and patients should stop using the affected devices and contact Mederi Therapeutics, Inc. for further instructions or a replacement.
The recalled product
- Product
- Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
- Manufacturer
- Mederi Therapeutics, Inc
- Affected units
- 1,458
Distribution
Distributed nationwide across the United States.
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