FDA Device recall Z-1330-2024
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 by Covidien, citing packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1330-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Covidien |
| Distribution | US |
Product
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Reason
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
Identifiers
| code_info | UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1330-2024%22
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