Covidien Kerlix Super Sponge Saline Dressing — Class II medical device recall Z-1743-2017
Terminated recall by Covidien LLC, reported 2017-04-12, distributed nationwide. Product sterility is compromised due to breach of sterile barrier
| Recall number | Z-1743-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-03-03 |
| Classified | 2017-04-06 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2019-10-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CZ, DK, EG, ES, FR, GB, GR, HU, IE, IL, IT, JP, KE, LU, MX, NL, NO, PH, PL, PT, RU, SA, SG, SK, ZA |
| Quantity | 38,794 |
| Reason classes | sterility |
| Model numbers | 3338 |
Product
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Reason for recall
Product sterility is compromised due to breach of sterile barrier
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1743-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.