Z-1591-2018 Class II Terminated
FDA device recall Z-1591-2018 was initiated by Cook Inc. on Jan 31, 2018 and is designated Class II. Reason for recall: The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. The recall status is terminated (terminated Apr 17, 2020). Affected quantity: 629.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Jan 31, 2018
- Termination Date
- Apr 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 629
Product Description
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Reason for Recall
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
Distribution Pattern
US Nationwide, OUS countries: AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DJ, DK, DO, EC, EE, EG, ES, FI, FJ, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IT, JO, KZ, LB, LT, LV, MA, MO, MX, MY, NI, NL, NO, NZ, PE, PH, PK, PL, PR, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, XK, ZA
Code Information
All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1591-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026