Surgical kits recalled due to compromised sterile wrapping
Medline Industries is recalling multiple CENTURION MEDICAL PRODUCTS surgical kits because perforated packaging compromises the sterile barrier. Only contents inside the kit wrapping maintain sterility.
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: FDA Class II recall involving a risk-of-harm product—surgical kits with compromised sterility could lead to post-operative infections. No illnesses or injuries have been reported, keeping the score at 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple CENTURION MEDICAL PRODUCTS surgical convenience kits, including chest tube insertion trays, vasectomy kits, laceration trays, suture sets, and umbilical catheter insertion trays. A total of 2,753 units were distributed nationwide.
The recall is due to perforations in the outer packaging bag. These perforations prevent the exterior packaging from maintaining sterility, leaving only the contents inside the kit wrapping sterile. This packaging defect compromises the sterile barrier that these surgical kits are designed to provide.
This recall affects healthcare facilities and medical providers nationwide who received these kits. Healthcare professionals should verify they are not using affected lot numbers and contact their supplier or Medline Industries for guidance on returning or replacing the affected kits.
The recalled product
- Product
- Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d)…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,753
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 (20)
- a) Reorder Number CVI2105
- GTIN 40653160091546
- Lot #22HMD248
- b) Reorder Number MNS11975
- GTIN 40653160325292
- Lot #22HMD116
- c) Reorder Number SUT11670
- GTIN 40653160109762
- Lot #22HMB913
- d) Reorder Number SUT12060
- GTIN 40653160120279
- Lot #22HMC040
- e) Reorder Number SUT14705
- GTIN 40653160185438
- Lot #22HMF267
- 22HMF925
- f) Reorder Number SUT17190
- GTIN 40653160229231
- Lot #22HMC041
- g) Reorder Number SUT17195
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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