A receiving-and-audit checklist for surplus single-use medical devices, as of September 2026. It does not provide clinical or legal advice about using expired products.
Surplus single-use devices look like a bargain until you read the label: an expiry date, a lot number, and a sterile barrier that may have been compromised in storage. Unlike capital equipment, a single-use device has no “cosmetic condition” that matters. What matters is whether the product is still within its labeled life, traceable to a lot, and protected by an intact sterile barrier. This guide turns those three questions into a receiving protocol.
Reading the label: what each identifier tells you
Labels on sterile single-use devices commonly carry GS1 application identifiers. The (01) identifier holds the GTIN ¡ª the global trade item number that identifies the product. The (10) identifier holds the batch or lot number assigned by the manufacturer. The (17) identifier holds the expiry date and appears for sterile products; a manufacturing date, when present, uses (15). Some labels show these in human-readable form alongside the barcode, which is why “I can see a date” is not enough ¡ª you need to know which date it is.
Two common symbols deserve attention: the “use by” or “expiration date” symbol and the “do not use if packaging is damaged” symbol, which warns that the sterile barrier or its packaging may be compromised. If a symbol is unfamiliar, check the manufacturer’s labeling guide before accepting the product.
The three checks that decide acceptance
- Expiry: Is today’s date before the labeled expiry? Do not calculate “still good for a while” as a substitute for the manufacturer’s date.
- Lot traceability: Is the lot number recorded and consistent between the label and the packing documents? Lot numbers are the link to recall notices, sterility-test records, and manufacturer notifications.
- Sterile barrier integrity: Is the sterile packaging visibly intact? Check pouches and trays for holes, tears, broken seals, creases that open the seal, moisture stains, and damage that could have breached the barrier. A package that looks intact can still be suspect if its storage history is unknown.
Receiving inspection protocol
| Step | Check | Record |
|---|---|---|
| 1. Identity | GTIN/product description matches the order | Item code and description |
| 2. Expiry | Label date readable and in the future | Expiry date from the label |
| 3. Lot | Lot number readable and matches documents | Lot number |
| 4. Barrier | No holes, tears, seal breaks, or moisture | Photos of any damage |
| 5. Storage evidence | Shipping/storage history consistent with label limits | Carrier and storage notes |
| 6. Disposition | Accept, quarantine, or reject | Decision and reason |
Storage and handling evidence
A sterile barrier protects the product only within its labeled storage conditions. Heat, humidity, sunlight, and rough handling can all degrade the barrier or the product without visible damage at first glance. When surplus inventory changes hands, ask where and how it was stored, whether it was exposed to temperature extremes, and whether the storage records exist. “It sat in a clean closet” is not storage evidence; a temperature log or a carrier record is closer to one.
What auditors expect
Accreditation and internal audits look for the same discipline: documented receiving inspection, expiry and lot capture, a quarantine path for failures, and disposal records for expired or compromised product. Industry guidance on sterile barrier integrity has been tightening: industry media reported in July 2026 that ISO is developing a technical specification (ISO/CD TS 20327) covering how facilities should receive, handle, transport, and store packaged sterile devices once they are under facility control. Treat receiving inspection as a routine, documented process rather than a one-time check at purchase.
Quarantine, disposal and recall readiness
Receiving inspection does not end with an accept or reject decision. Rejected or expired units should move to a clearly identified quarantine area with a record of the decision and photos of the reason, and disposal should follow your facility’s policies and local regulations. The same lot records that support acceptance also support recall readiness: if a manufacturer issues a notice for a lot you hold, the GTIN, lot, expiry, and quantity fields let you identify exactly which units are affected without re-inspecting every carton. Keep a simple lot-level register for surplus purchases ¡ª item, GTIN, lot, expiry, quantity, receiving date, disposition ¡ª and update it when units are issued, returned, or destroyed. That register is the difference between a five-minute recall response and a warehouse-wide search.
Common labeling mistakes
Three labeling errors cause most receiving problems. The first is confusing the manufacturing date with the expiry date; on GS1-style labels the (15) identifier is manufacturing and the (17) identifier is expiry, and they can appear close together. The second is treating an outer-carton date as the product’s expiry; read the label on the individual sterile package, because the carton may contain mixed lots or near-expiry units. The third is accepting a mixed-lot carton without recording each lot separately. Damage also gets misread: a scuffed outer carton is not by itself a sterile-barrier failure, but it is a reason to inspect the inner packages carefully and to question the storage history. When symbols are missing or ambiguous, check the manufacturer’s labeling guide instead of guessing ¡ª the label is the only instruction set that governs that specific product.
Questions procurement teams ask
Can we use a sterile device after its expiry date?
No receiving protocol should accept expired sterile devices for clinical use. The expiry date is the manufacturer’s statement of the period within which sterility and performance are assured; do not override it with your own estimate.
What if only some units in a lot have damaged packaging?
Quarantine the damaged units and accept the rest only if their barriers are intact and their lot and expiry records are complete. Document the decision with photos.
Is a lot number enough for traceability?
Lot number alone is not enough; combine it with the GTIN, expiry date, and the quantity received so you can match a future recall notice to exactly the units affected.
Surplus single-use inventory is safe to buy only when every unit can answer three questions: Is it in date? Is the lot recorded? Is the sterile barrier intact? Use the protocol above on every carton, and quarantine anything that cannot answer. If you are sourcing single-use devices or related inventory, browse the HHG store and ask for lot and expiry records before you commit.