Surgical Convenience Kits Recalled Due to Non-Sterile Outer Packaging
Medline and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent sterility, leaving only the contents inside the kit wrapping sterile.
What this means for you
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 of surgical medical devices with a packaging sterility defect. Although no illnesses or injuries have been reported, the defect poses a risk of contamination in surgical use, justifying a High severity classification for a risk-of-harm product without reported injury.
Plain-English summary
Medline Industries, LP and Centurion Medical Products are recalling surgical convenience kits because the outer packaging has perforations that prevent it from being sterile. This means only the contents inside the kit wrapping maintain their sterility, while the external packaging does not.
The recall involves five product variants: the Medline Hand Pack, Medline Shoulder Suspension II-LF, Medline Bone Marrow ASC LTX Safe Tray, Medline Lumbar Tray, and Centurion Medical Products Lumbar Puncture Kit. A total of 4,779 units have been distributed nationwide. Specific lot numbers have been identified for each product as detailed in the recall notice.
The recalled product
- Product
- Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- sterility-defect
- contamination-risk
- packaging-defect
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 (15)
- a) Reorder Number DYNJ67850
- GTIN 10193489445541
- Lot # 22BBJ239
- b) Reorder Number DYNJSHOULDER2
- GTIN 10884389097458
- Lot # 22DBN344
- c) Reorder Number P429589A
- GTIN 40889942436348
- Lot # 22HME367
- d) Reorder Number SPEC0177
- GTIN 40884389914657
- Lot # 22MBA770
- e) Reorder Number PT235A
- GTIN 40653160992746
- Lot # 22HMH321
Distribution
Distributed nationwide across the United States.
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