CLASS II ONGOING Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
Medline Sirus Surgical Gown, Strong Protection recalled
Master & Frank (Pinghu) is recalling Medline Sirus Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, distributed in Illinois. The recall was initiated on 1 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3079-2017
- FDA event ID
- 77633
- Recalling firm
- Master & Frank (Pinghu), Hangzhou, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2017
- FDA classified
- 28 Aug 2017
- Reported
- 6 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 1 Jun 2017 | Recall initiated by company | |
| 28 Aug 2017 | Classified by FDA | +88 days |
| 6 Sep 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Domestic: IL.
Questions about this recall
Why was it recalled?
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
Which lots are affected?
Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
Where was it sold?
Domestic: IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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