EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires
EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is driven by regulatory non-compliance (lack of registration and quality system) rather than a specific product defect or reported harm. This aligns with the 'Moderate' criterion for voluntary precautionary or administrative recalls where no immediate physical hazard is explicitly detailed.
Plain-English summary
EXP Pharmaceutical Services Corp is recalling 19 units of sterile, single-use nonabsorbable sutures and sternotomy wires. The products are identified by OEM catalog numbers 046-072 and 046-073 and were distributed in the District of Columbia and the states of Colorado, California, Florida, Texas, and Arkansas.
The recall was initiated because EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system. The company relied on its vendors' registrations and quality systems instead of maintaining its own compliance.
No specific illnesses or injuries are reported in the source text. Consumers and healthcare facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
- Manufacturer
- EXP Pharmaceutical Services Corp
- Affected units
- 19
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 (2)
- OEM Catalog number 046-072
- 046-073.
Distribution
Part of a larger recall action
This product is one of 42 recalled by EXP Pharmaceutical Services Corp 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.
See all 42 products in this recall →Related recalls
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