FDA-Device2024-10-30Class II
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTO
MEDLINE INDUSTRIES, LP - Northfield
Hazard
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Affected count
1048 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A; b) DR SELEM PACK, REF DYNJ43457; c) BREAST PK TEGH-LF, REF DYNJ46717A; d) BREAST PK TEGH-LF, REF DYNJ46717A; e) BREAST BIOPSY-LF, REF DYNJ53205B; f) BREAST BIOPSY-LF, REF DYNJ53205B; g) PLASTIC PACK, REF DYNJ57895; h) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803; i) BREAST PACK, REF DYNJ64376; j) CSTM PK SURGISTART MAINE PLAST, REF DYNJ66619A; k) PLASTIC PACK, REF DYNJ68030; l) CUSTOM PLASTIC PACK, REF DYNJ68062; m) PLASTIC LIMB SJHC-LF, REF DYNJ84997
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2025Don't want to check this manually?
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