Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Sterile Procedural Trays
- labeled as the followinga. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 1019348920552740193489205528GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/ , Lot Number: 22JDA531,22IDB178,22IDA705 1019348990118440193489901185OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/ , Lot Number: 22JBS296 1019348973536940193489735360VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/ , Lot Number: 22KBB429,22IBE503 1019348945789640193489457897DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/ , Lot Number: 22JMC869,22JMC852,22HMD762 1019348981415640193489814157MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/ , Lot Number: 22IDC043 1019348921414740193489214148GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/ , Lot Number: 22JDA984 - Amount recalled
- 194 cases (508 units)
This recall covers 38 products
The agency filed one notice per product. You are reading one of them; the other 37 are below.
25 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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