StoneBreaker Sterilization Cap recall: Sterility Concern
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Why was StoneBreaker Sterilization Cap recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
- Recalling firm
- Cook Inc.
- Quantity
- 470
- Distribution
- 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
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)