Laparotomy Sponges recalled for incomplete sterilization and missing RF detection
Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving surgical sponges with potential for serious infection and sepsis if non-sterile units are used in surgical procedures. No illnesses or injuries have been reported. Per the rubric, Class II recalls without reported hospitalizations that present risk of serious harm score as High (3).
Plain-English summary
Covidien is recalling the Situate Laparotomy Sponge (REF: L1818-04P01C-1) because certain packs may contain incorrect product that was not steam pre-treated prior to sterilization. These sponges are treated with ethylene oxide but lack the required RF (radio frequency) detection tag.
The affected product was distributed nationwide to 34 states, with affected lot numbers 230504KF, 220903KF, and 221102KF. Approximately 755,800 units are involved in this recall. If these non-sterile sponges are used in surgical procedures, they may cause infection, tissue trauma, and sepsis.
Healthcare facilities that received affected lots should immediately identify and quarantine the product. Facility staff should verify the presence of the RF tag on laparotomy sponges before use. Any distributed sponges without the RF tag or steam pre-treatment should not be used in surgical procedures.
The recalled product
- Product
- Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Manufacturer
- Covidien
- Category
- Medical Device — Surgical Sponge
- Hazard
- non-sterile
- infection
- sepsis
- tissue-trauma
- sterilization-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 20884521700953
- 10884521700956. Lots: 230504KF
- 220903KF
- 221102KF
Distribution
Distributed nationwide across the United States.
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