Recall of MEDLINE SIRUS Surgical Gowns Due to Inconsistent Sleeve Sealing
Master & Frank (Pinghu) Co., Ltd. is recalling 2,160 units of MEDLINE SIRUS Surgical Gowns because inconsistent sleeve seam sealing may allow fluid to pass through.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (surgical gown) where the defect could compromise protection, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Master & Frank (Pinghu) Co., Ltd. is recalling 2,160 units of MEDLINE SIRUS Surgical Gowns, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gowns. The affected units were sold in kits with sterile gowns, hand towels, and CSR wraps, as well as in boxes of 18 gowns. The specific lot number is 45016070513PH and the reference number is DYNJP2229S.
The recall was initiated because the sleeve seam of the breathable material was found to have inconsistent sealing. This defect has the potential to allow fluid to flow past the protective seam, which could compromise the protective function of the gown.
The affected units were distributed domestically in Illinois. Consumers and healthcare facilities should stop using the recalled gowns and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
- Manufacturer
- Master & Frank (Pinghu) Co., Ltd.
- Category
- Medical Device — Surgical Gowns
- Affected units
- 2,160
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 (2)
- Reference No. DYNJP2229S
- Lot/Serial No. 45016070513PH
Distribution
Distributed in 1 state:
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